The Tolerability Profile of Clindamycin 1%/Benzoyl Peroxide 5% Gel vs. Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel for Facial Acne: Results of Two Randomized, Single-Blind, Split-Face Studies

Objective: To compare the first two weeks of tolerability of clindamycin/benzoyl peroxide gel versus adapalene/benzoyl peroxide gel followed by six weeks of open-label clindamycin/benzoyl peroxide gel therapy in subjects with mild-to-moderate acne who participated in two eight-week, identically designed, clinical studies. Methods: Using a split-face method, patients received both clindamycin/benzoyl peroxide gel and adapalene/benzoyl peroxide gel once daily for two weeks (allocation to the right or left side of the face was randomized) in an investigator-blinded fashion. Patients then went on to receive a further six weeks of open-label, full-face clindamycin/benzoyl peroxide gel. The primary outcome was to compare signs and symptoms of tolerability during the first two weeks of treatment using an investigator-assessed 4-point rating scale. Secondary endpoints included assessment of acne severity (Investigator Static Global Assessment and lesion counts), quality of life, product acceptability/preference, and patient assessments of tolerability and safety. Results: Of the 76 subjects enrolled in the two studies, 72 completed them. Overall both products were well tolerated, but mean scores for erythema, dryness, and peeling were significantly higher with adapalene/benzoyl peroxide gel than with clindamycin/benzoyl peroxide gel at both Weeks 1 and 2 (p<0.03). Patients also rated clindamycin/benzoyl peroxide gel significantly more tolerable than adapalene/benzoyl peroxide gel for redness, dryness, burning, itching, and scaling at Weeks 1 and 2 (p 0.0073). Mean Investigator Static Global Assessment score improved with both products during the first two weeks of treatment and continued to show significant improvement versus baseline when treatment with clindamycin/benzoyl peroxide gel was continued for a further six weeks (p<0.001 at Week 8). Lesion counts improved throughout the study with significant reductions from baseline occurring at Weeks 5 and 8 (p<0.0001 for both time points for total lesion counts). Clindamycin/benzoyl peroxide gel and adapalene/benzoyl peroxide gel were well tolerated, with most adverse events of mild-to-moderate severity. Conclusion: Clindamycin/benzoyl peroxide gel had better tolerability with regard to erythema, dryness, and peeling than adapalene/benzoyl peroxide gel during the first two weeks of treatment.     

Tazarotene 0.045% Lotion for Moderate-to-Severe Acne in Male and Female Participants: A Phase II Post-hoc Analysis

CLINICAL TRIALS ID: {"type":"clinical-trial","attrs":{"text":"NCT02938494","term_id":"NCT02938494"}}NCT02938494BACKGROUND: In a Phase II study, tazarotene 0.045% lotion was statistically superior to vehicle and comparable to tazarotene 0.1% cream in reducing acne lesions, with fewer treatment-related adverse events (TEAEs) than the cream. OBJECTIVE: We analyzed data from the aforementioned study post-hoc to evaluate the effects of sex on treatment outcomes. METHODS: Participants aged 12 years or older with moderate-to-severe acne were randomized to tazarotene (0.045% lotion or 0.1% cream) or vehicle (lotion or cream) for 12 weeks of double-blind treatment. Outcomes analyzed in male and female subgroups included changes from baseline in inflammatory/noninflammatory lesions and TEAEs. RESULTS: In the intent-to-treat population (94 males and 116 females), reductions in lesion count were greater with tazarotene (lotion or cream) than with vehicle. In participants receiving tazarotene 0.045% lotion, the least-squares mean percent changes from baseline to Week 12 were greater in females than males, but the differences were not statistically significant (inflammatory [−70.3% vs. −56.2%]; noninflammatory [−60.0% vs. −53.2%]). In both females and males, the TEAE incidence was lower with tazarotene 0.045% lotion than 0.1% cream. CONCLUSION: Tazarotene 0.045% lotion substantially reduced acne lesions in both female and male participants. This newest tazarotene formulation might benefit patients who cannot tolerate older formulations or other topical retinoids. Given the relatively small size of this study, however, the results of this post-hoc analysis are intended to be exploratory in nature.     

Cutaneous Safety and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate-to-severe Acne Vulgaris

Objective: To investigate the cutaneous safety and tolerability of clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel in moderate-to-severe acne patients. Methods: A safety assessment of 498 patients with moderate-to-severe acne receiving clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel or vehicle for 12 weeks. Results: The vast majority (80-95%) of patients reported no cutaneous safety or tolerability problems throughout the study. Mean scores for both active and vehicle were all <1 (where l=mild) and reduced over the duration of the study. When scaling, erythema, itching, burning, or stinging was reported it was generally mild. Moderate or severe reactions to clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel were rare and generally seen early in treatment. There were eight reports (3.3%) of moderate erythema, four reports (1.7%) of moderate scaling, three reports (1.2%) of moderate itching, and one report of moderate burning (0.4%) at Week 4. There was one report (0.4%) of severe erythema and one report (0.4%) of severe burning (both at Week 4), with one report (0.4%) of severe stinging at Week 12. There were no substantive differences seen in cutaneous tolerability among treatment groups and younger patients tended to have milder reactions. Limitations: It is not possible to determine the contributions of the individual active ingredients. Conclusion: Clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel has a favorable safety and tolerability profile with very low incidence of moderate or severe reactions.The treatment of a chronic disease, such as acne, is a long-term process complicated by adolescent patients’ tendency for poor treatment adherence.1–3 Typically, moderate acne will improve in 20 to 40 percent of patients within 12 weeks, and 50 percent or better by Week 26.4 Compliance has been reported as low as 45 percent for daily application of topical antimicrobial acne treatments.5 Indeed it has been suggested that poor adherence may be the most important factor in the failure of acne treatment.6Cutaneous safety and tolerability of topical medications is a key determinant in patient adherence; however, good data on the association between tolerability and adherence is lacking.7 One study that did find an association showed that patients treated with an adapalene/benzoyl peroxide (BP) 2.5% fixed combination missed more doses as a result of irritation and adverse events than with a less irritating clindamycin/BP 5% fixed combination product.8How much patients are bothered by dryness and irritation from topical acne treatments and what action they take as a result is not well-characterized. It is well known that a potential limitation of BP is concentrationdependent irritation.9 An internet-based survey of patients using clindamycin/BP 5% showed bothersome side effects, such as dry skin, flaky/peeling skin, irritation, itchiness, and redness to be very common, having a number of impacts on treatment patterns.10 It was noted that to combat irritation, patients would often resort to treating spots only, using the product only when breakouts seemed worse, using the product sporadically, or switching to an over-the-counter product.10 Topical retinoids are also potentially irritating to the skin, with dryness, erythema, stinging, and pruritus being common, especially over the first few weeks of therapy.11Combining multiple therapies that are all potentially irritating can be a challenge. However, advances in formulation research, including the removal of potentially irritating surfactants, preservatives, alcohol, and parabens has lead to the introduction of fixed combinations with favorable cutaneous safety and tolerability profiles.12 Recently, efficacy and tolerability data on a new fixed combination product, clindamycin phosphate 1.2%/BP 3.75% gel was reported.13 In this paper, the cutaneous safety and tolerability is looked in greater detail, both in the overall population and outliers.     

夫西地酸乳膏联合阿达帕林凝胶治疗寻常痤疮疗效观察

目的评价2％夫西地酸软膏联合0．1％阿达帕林凝胶治疗轻中度寻常痤疮的临床疗效及安全性。方法选择2011年1月～2013年1月某院收治的寻常痤疮130例,根据治疗方法的不同将患者分为治疗组和对照组。治疗组66例,采用2％夫西地酸软膏联合0．1％阿达帕林凝胶治疗;对照组64例,单独使用0．1％阿达帕林凝胶治疗。两组患者均连用8周,分别在治疗后第2,4,8周末观察疗效并评价安全性。结果治疗后第8周,治疗组有效率86．4％,对照组有效率52．5％,两组比较差异有显著性（P〈0．05）。结论2％夫西地酸软膏联合0．1％阿达帕林凝胶治疗轻中度寻常痤疮疗效满意。     

1%线状透明颤菌面霜在中国女性敏感性皮肤的功效与耐受性评价

目的评价温泉浮游生物纯提取物(pureextractthermalplankton,PETP)即线状透明颤菌(Vitreoscillafiliformis,VF)提取物用于中国女性敏感性皮肤的功效与耐受性。方法经临床检查和乳酸刺激实验筛选出伴有敏感性皮肤的健康女性36例。早晚清洁面部后,均匀涂抹1%VF面霜,每日2次,连续使用3周。分别于实验前后由同一个皮肤科医师观察受试者的皮肤乳酸刺激分数,以及皮肤的临床表现(干燥、红斑、鳞屑、弹性、光滑度)。同时,检测皮肤颜色及皮肤角质层水合度等皮肤生物学参数。结果受试者的乳酸刺激分数显著降低,使用前后差异显著(P<0.0001)。干燥、红斑、鳞屑、光滑度均有不同程度改善。受试者对VF面霜耐受良好。结论伴有敏感性皮肤的中国女性,在皮肤日常护理中,使用含有VF提取物的护肤品有助于改善皮肤的敏感状态和皮肤保健。     

Once-daily Dapsone 7.5% Gel for the Treatment of Acne Vulgaris in Preadolescent Patients: A Phase IV,Open-label, 12-week Study

CLINICAL TRIALS ID: {"type":"clinical-trial","attrs":{"text":"NCT02959970","term_id":"NCT02959970"}}NCT02959970 BACKGROUND: Acne vulgaris in patients aged younger than 12 years is increasingly common and primarily noninflammatory (i.e., comedonal). Dapsone 7.5% gel is indicated for the topical treatment of acne vulgaris in patients nine years of age or older. OBJECTIVE: We sought to evaluate efficacy, safety, tolerability, and pharmacokinetics (PK) of once-daily topical dapsone 7.5% gel. METHODS: This was a Phase IV, multicenter, open-label study in patients with acne aged 9 to 11 years. Patients applied dapsone 7.5% gel once daily to the face and acne-affected areas on the upper chest, upper back, and shoulders for 12 weeks. Patients in the PK cohort applied dapsone 7.5% gel under maximal-use conditions for eight days and a thin layer for the remaining 11 weeks. Lesion counts and proportions of patients with an Investigator’s Global Assessment score of zero points (clear) or one point (almost clear) were assessed. Plasma concentrations of dapsone and metabolites were evaluated after one week in the PK cohort. Safety and dermal tolerability were evaluated. RESULTS: After 12 weeks, facial acne was clear or almost clear in about 47 percent of patients. Inflammatory, noninflammatory, and total lesions decreased from baseline, with a greater reduction apparent in noninflammatory lesions. Systemic exposure to dapsone in PK patients was low. The overall rate of adverse events was low, and dermal tolerability scores indicated no or mild stinging/burning, dryness, scaling, and erythema. CONCLUSION: Once-daily topical dapsone 7.5% gel used for 12 weeks was safe, effective, and well tolerated in preadolescent patients with acne.     

Open-Label Treatment of Moderate or Marked Melasma with a 4% Hydroquinone Skin Care System Plus 0.05% Tretinoin Cream

Objective: To evaluate treating epidermal melasma using a 4% hydroquinone skin care system plus tretinoin 0.05% cream. Design: Multicenter open-label study with all patients receiving above-mentioned treatment for up to 24 weeks. Setting: Private dermatology and plastic surgery clinics and clinical research facilities. Participants: Thirty-seven adult females with moderate or marked epidermal melasma, melasma pigmentation of mild-to-marked intensity and Fitzpatrick skin type III to VI. Measurements: Melasma severity melasma pigmentation intensity melasma improvement, patient satisfaction, quality-of-life measures, erythema, dryness, peeling, burning/stinging. Results: No patient discontinued due to lack of efficacy or treatment-related adverse events. Treatment was associated with a significant reduction from baseline in melasma severity and melasma pigmentation intensity from Week 4 onward (P≤0.001), and 100 percent of patients showed improvement from Week 8 onward. At Week 24, 100 percent of patients were “satisfied” or “very satisfied” with the overall effectiveness of their treatment. Patients’ quality of life also improved (e.g., the proportion of patients feeling embarrassed or self-conscious about their skin “a lot” or “very much” declined from 78 percent at baseline to four percent at Week 24). Mean and median scores for erythema, dryness, peeling, and burning/stinging did not exceed trace levels. Conclusion: Treating moderate-to-severe melasma using the 4% hydroquinone skin care system plus 0.05% tretinoin can significantly reduce the severity of melasma and the intensity of melasma pigmentation within four weeks. Treatment was generally well tolerated and associated with an improved quality of life and high levels of patient satisfaction.Despite the potential of melasma for causing considerable negative effects on emotional wellbeing and quality of life,1 it has been reported that the condition may be undertreated.2 Hydroquinone is well known as being effective in reducing hyperpigmentation in a variety of conditions and it is commonly used in conjunction with tretinoin in the treatment of melasma. Triple combination therapy, which contains a corticosteroid as well as hydroquinone and tretinoin, may also be used. However, the presence of the steroid can limit the clinical usefulness of such therapy as the only triple therapy combination product approved by the United States Food and Drug Administration (FDA) is indicated for short-term use only (up to 8 weeks).3 As melasma is prone to relapse, it may be easier and safer to manage the condition using a steroid-free treatment that is suitable for longer term treatment.When any dermatological treatment is recommended, it is prudent to consider how easy it will be for patients to incorporate the new regimen into their existing skin care routine because if patients become confused juggling different regimens, this may result in poor compliance and suboptimal dinical outcomes. This is especially important in conditions such as melasma where the majority of patients are female4 and where long-term treatment may be needed. By offering an easy-to-follow regimen that provides both overall skin care and treatment for a specific skin condition, skin care systems have proven very popular with patients.A skin care system is available that incorporates a 4% formulation of hydroquinone into a comprehensive skin care regimen providing cleansing, toning, exfoliation, and photoprotection. Photoprotection is always essential to achieve and maintain efficacy in melasma and the proprietary cleanser, toner, and exfoliant are each designed to facilitate the penetration of other ingredients in the system into the skin. In this way, the system aims to achieve superior clinical outcomes than might be achieved with the uncoordinated use of standard products. The authors conducted a multicenter study to evaluate treating epidermal melasma with this 4% hydroquinone skin care system in conjunction with tretinoin 0.05% cream for up to 24 weeks.     

Epidural infusions for labor analgesia: A comparison of 0.2% ropivacaine, 0.1% ropivacaine,and 0.1% ropivacaine with fentanyl

Background and Objectives: Epidural infusion of 0.2% ropivacaine is recommended by the manufacturer for labor analgesia, but lower concentrations may be effective. The objective of this study was to compare 0.1% ropivacaine with 0.2% ropivacaine and to examine the effect of addition of fentanyl. Methods: In a randomized double-blind study, 58 nulliparous laboring parturients had epidural analgesia established with 0.2% ropivacaine and were then randomized to receive one of the following epidural infusions at 10 mL/h: 0.2% ropivacaine (group R2, n = 19), 0.1% ropivacaine (group R1, n = 19), or 0.1% ropivacaine with 2 [mu ]g/mL fentanyl (group RF, n = 20). Supplementary analgesia was provided on request with 5-mL boluses of 0.2% ropivacaine. Results: All solutions provided effective analgesia during early labor, with all groups requiring similar numbers of supplementary top-ups. Visual analog pain scores in groups R2 and RF were equivalent and lower than in group R1 (P = .006). Hypotension was more frequent in group RF compared with groups R2 and R1 (P = .014). Patient and midwife satisfaction and obstetric and neonatal outcomes were similar among groups. Maternal venous plasma concentrations of ropivacaine were greater in group R2 compared with groups R1 and RF (P = .008), but umbilical venous concentrations were similar. Conclusions: We conclude that epidural infusion of 0.1% ropivacaine alone at 10 mL/h provided adequate analgesia in the first stage of labor, and that the addition of 2 [mu ]g/mL fentanyl to that concentration improved analgesia to a quality similar to 0.2% ropivacaine alone. Reg Anesth Pain Med 2002;27:31-36.     

In-vivo Effectiveness of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel on Antibiotic-sensitive and Resistant Propionibacterium acnes

Background: A gel combination treatment containing a retinoid (adapalene 0.1%) and an antimicrobial (benzoyl peroxide 2.5%) has been shown to be an effective treatment for acne vulgaris, addressing three of the four pathogenic factors (hyperkeratinization, Propionibacterium acnes proliferation, inflammation) without contributing to the incidence of Propionibacterium acnes antibiotic resistance as neither the retinoid nor benzoyl peroxide creates selective pressure for resistance. Objective: To evaluate the effectiveness of an adapalene-benzoyl peroxide gel combination in reducing antibiotic-sensitive and resistant strains of Propionibacterium acnes on the facial skin of volunteers. Methods: This four-week, open-label, single-center study included 30 healthy adults with high facial Propionibacterium acnes populations [>10(4) colony-forming units per square centimeter of skin (CFU/cm(2))] and presence of subpopulations resistant to erythromycin, tetracycline, and clindamycin. The gel was applied once daily to the forehead. Cultures for total and antibiotic-resistant Propionibacterium acnes were obtained from the forehead area at screening, Baseline, Week 2, and Week 4. Results: Total Propionibacterium acnes counts decreased by 1.1 log(10) CFU/cm(2) after two weeks of treatment, and by 1.6 log10 CFU/cm(2) after four weeks. All subjects had strains resistant to each of the five antibiotics at baseline. Mean counts of erythromycin and clindamycin resistant Propionibacterium acnes were high at baseline (5.37 and 5.28 log(10) CFU/cm(2), respectively) and decreased by ≥2.1 log(10) by Week 4 (P<0.001). Mean counts of strains resistant to tetracyclines were lower at baseline (3.8 to 4.2 CFU/cm(2)) and decreased by 1.9 (tetracycline), 2.4 (minocycline), and 1.3 (doxycycline) log(10) CFU/cm(2) by Week 4 (P<0.001). Limitations: Although limited in scope, the results of the present study demonstrate that the fixed-dose combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% effectively inhibited both antibiotic-susceptible and antibiotic-resistant Propionibacterium acnes. In addition to reducing population densities, therapy with adapalene-benzoyl peroxide eradicated some resistant strains entirely in some individual subjects. Conclusion: Topical adapalene-benzoyl peroxide gel effectively reduced skin colonization by antibiotic-sensitive and antibiotic-resistant Propionibacterium acnes after four weeks. This trial was registered with ClinicalTrials.gov (http://clinicaltrials.gov/), registry number NCT00907101.     

Doxepin cream vs betamethasone cream for treatment of chronic skin lesions due to sulfur mustard

Oral doxepin was shown to reduce chronic pruritus due to sulfur mustard. The present study compared the effects of topical doxepin 5% with betamethasone 1% for the treatment of pruritus in veterans exposed to sulfur mustard. This investigator-blinded, randomized, clinical trial was conducted in an outpatient dermatology clinic. Seventy-five men who were exposed to sulfur mustard 23 to 28 years ago during the Iran-Iraq war who complained of pruritus were randomized to receive doxepin cream 5% (n = 40) or betamethasone cream 0.1% (n = 35) twice a day for 6 weeks. Pruritus severity and Dermatology Life Quality Index (DLQI) were evaluated before and after each treatment. Both groups showed significant improvement regarding pruritus (P < .05), burning sensation, skin dryness (P < .001), and skin scaling (P < 0.05). The lesions of all regions significantly reduced after treatments (P < .05), except those on the head, face, and genitalia. Pruritus, visual analog scores, and DLQI significantly decreased (P < .01, P < .01, and P < .001, respectively) in doxepin- and betamethasone-treated groups, and there was no difference between groups. All DLQI subscores decreased after both type of treatments (P < .01). Equal efficacy of doxepin cream and betamethasone suggest that doxepin is a potential alternative to control pruritus caused by sulfur mustard in exposed veterans.     

Phimotic ring topical corticoid cream (0.1% mometasone furoate) treatment in children

Background/Purpose

Phimosis, owing to the presence of a preputial fibrotic ring, is surgically treated in 1% of children. During the last decade, however, topical steroid treatment has been proposed for phimosis.

Methods

We present a double-blind study comparing 0.1% mometasone furoate topical cream vs moisturizing cream (placebo) for the treatment of phimosis. Children aged from 2 to 13 years (n = 110) presenting with phimosis (Kikiro's classification grade 5) and scheduled for circumcision were included in this trial. The patients were evaluated after 8 weeks of topical treatment with moisturizing cream (n = 54) or steroid cream (n = 56). Nonresponders from both groups received an additional 8 weeks of steroid cream treatment.

Results

In the steroid group, the ring disappeared and glans exposure was obtained in 49 (88%) of 56 patients vs 28 (52%) of 54 patients in the placebo group (P < .05). After a second treatment, in the steroid group, 5 of the 7 patients were finally cured vs 22 of the 26 in the placebo group (P < .05). Two children with persisting phimosis (Kikiro's retractability grade 5 and appearance grade 3) in the steroid group (4%) vs 4 children in the placebo group (7%) ended up receiving postectomy.

Conclusions

The present investigation adds up and supports the effectiveness of phimosis topical corticoid treatment. Nevertheless, hygiene and preputial traction, when appropriately performed, seem to play an important role in the disappearance of the phimotic ring as well. New studies are necessary to confirm if this is true or not.     

Effectiveness and Patient Acceptance of Halcinonide 0.1% Cream in 216g Jars for Large-area Steroid-responsive Dermatoses

When treating patients with extensive dermatitis, total body surface area affected must be considered when prescribing topical medication. Halcinonide 0.1% cream, a class 2 topical corticosteroid, is now available in a 216g jar. This large size is convenient and cost effective for patients with large-area dermatoses. Objectives: The objectives of this study were to determine the efficacy and patient acceptance of halcinonide in 216g jars for the treatment of large-area dermatoses. Design: This study was an open-label, noncomparator trial evaluating the clinical outcomes and acceptability of halcinonide in 216g jars. Halcinonide was prescribed twice daily for up to 28 days. Measurement: Severity of dermatoses was based on investigator observations at the baseline visit and again after 28 days. Patient satisfaction was evaluated based on a questionnaire completed at the conclusion of the study. Results: Total enrollment was 40 patients. Dermatoses affected an average of 12 percent body surface area. At baseline, all patients exhibited dermatoses rated as severe or moderate. Nearly half of patients were completely cleared or almost cleared by 28 days, with all patients noting at least some improvement. Most patients agreed that they liked the way the product spread on the skin (94.7%), and more than 80 percent found that it was neither sticky nor greasy. In more than 90 percent of cases, the investigator reported that halcinonide provided a shorter duration of therapy versus triamcinolone one-pound jars. Conclusion: Halcinonide 0.1% cream in 216g jars is effective and convenient for patients with large-area dermatoses.     

Treatment of scalp and facial seborrheic dermatitis with desonide hydrogel 0.05%

Background: Desonide is a low-potency corticosteroid recently formulated in a novel aqueous gel (hydrogel) formulation. Currently US Food and Drug Administration approved for use in the treatment of mild-to-moderate atopic dermatitis, this hydrogel formulation may offer aesthetic advantages over traditional vehicles. Objective: To conduct a pilot study evaluating efficacy, tolerability, and patient preference of desonide hydrogel 0.05% for the treatment of scalp and facial seborrheic dermatitis. Methods:Subjects treated affected areas on the face or scalp twice daily for four weeks. Evaluations of pruritus, target area scaling, induration and erythema; static global assessments; and photography were conducted. Results: Ten subjects aged 13 to 73 years with mild scalp or facial seborrheic dermatitis completed the study. Statistically significant reductions in pruritus, target area scaling, erythema, and induration, and significant improvements in static global assessments were demonstrated over Baseline (all P<0.05). Conclusion:Desonide hydrogel 0.05% may provide an effective, well-tolerated, and cosmetically elegant treatment option for scalp and facial seborrheic dermatitis.     

Clinical Comparison of Topical 2.5% Benzoyl Peroxide plus 5% Niacinamide to 2.5% Benzoyl Peroxide Alone in the Treatment of Mild to Moderate Facial Acne Vulgaris

BackgroundThe combination of benzoyl peroxide and a new topical therapy, such as topical niacinamide, reduces facial sebum production and also has a skin-lightening effect. This combined treatment might lead to improved efficacy in the treatment of facial acne vulgaris while also promoting the resolution of postacne erythema and postinflammatory hyperpigmentation.ObjectiveThe primary objective was to evaluate and compare the clinical efficacy of topical 2.5% benzoyl peroxide plus 5% niacinamide and 2.5% benzoyl peroxide with cream base for mild to moderate facial acne vulgaris. Secondary objectives were to evaluate and compare clinical efficacy regarding postinflammatory hyperpigmentation, postacne erythema, reduction of facial sebum production, and side effects. METHODS: Patients with mild to moderate facial acne vulgaris and aged 18 to 40 years were enrolled. Treatment was randomly assigned to the left or right side of the face for 12 weeks. Both inflammatory and noninflammatory acne lesions were counted by a physician, and the postinflammatory hyperpigmentation score and postacne erythema score were calculated using an Antera 3D^® camera (Miravex, Dublin, Ireland). Sebum casual level was measured using a Sebumeter^® (Courage+Khazaka Electronic, Köln, Germany) every two weeks. Physician improvement score, patient satisfaction index, and side effects were assessed by evaluation forms every two weeks.ResultsAt Week 12, the niacinamide group (5% niacinamide+2.5% benzoyl peroxide) showed significant reduction in both the acne lesion count and sebum casual levels from baseline (p=0.000 and p=0.001, respectively). The reduction in noninflammatory lesion count in the niacinamide group was better than that in the cream base group (2.5% benzoyl peroxide+cream base), with a statistically significant difference (p=0.004). However, the reduction in inflammatory lesions was not significantly different between the two groups. The sebum casual level in the niacinamide group was reduced faster than that in the cream base group. The postacne erythema score was reduced from baseline in both groups, with no statistically significant difference within or between the two groups. The postinflammatory hyperpigmentation score showed increases in both groups above the baseline, with a statistically significant difference in the cream base group (p=0.000) but no such difference in the niacinamide group (p=0.58). There was no statistically significant difference between the two groups. Furthermore, no statistically significant differences were found between the two groups at every follow-up visit in terms of physician improvement scale, patient satisfaction index, or side effects.Conclusion The combination of 2.5% benzoyl peroxide and 5% niacinamide is more effective than 2.5% benzoyl peroxide alone for mild to moderate facial acne vulgaris.     

Creme tópico de capsaicina (8%) para o tratamento da síndrome da dor miofascial

BackgroundMyofascial pain syndrome is a common cause of musculoskeletal pain. The objective of this study was to evaluate the potential analgesic action of 8% capsaicin cream for topical use in patients with myofascial pain syndrome.MethodsInitially, cream formulations of PLA (Placebo) and CPS (Capsaicin 8%) were developed and approved according to the current requirements of the health authority agency. The 40 participating patients were randomly assigned to the PLA and CPS groups in a double‐blind fashion. Before the creams were topically administered, according to the allocation group, the local anesthetic was used for a period of 50 minutes directly in the area of interest. The cream was applied to the area of the skin over the trigger point, represented by the area with pain at palpation, in an amount of 10 g for 30 minutes in a circular area of 24 mm diameter. Subsequently, the cream was removed and the skin tolerability parameters were evaluated. The pain was measured before and during the formulation application, as well as at 1 hour, 7 days, 30 days, and 60 days after the procedure, evaluated using a verbal numerical scale (from 0 to 10: with 0 = no pain and 10 = worst pain imaginable).ResultsNo patient in PLA Group had hyperemia or burning sensation at the site of application, while 85% of patients in CPS Group had hyperemia or burning sensation at 15 minutes. These complaints disappeared 24 hours after the cream was removed. The pain score in CPS Group decreased steadily up to the 60^th day of evaluation (p < 0.0001).ConclusionApplication of the formulations did not cause macroscopic acute or chronic skin lesions in patients, and the 8% capsaicin formulation was beneficial and well tolerated.     

Safety and Cosmetic Effects of Photodynamic Therapy using Hexyl Aminolevulinate and Intense Pulsed Light: A Pilot Study Conducted in Subjects with Mild-to-moderate Facial Photodamage

Objective: To assess the cosmetic effects of photodynamic therapy with hexyl aminolevulinate cream and intense pulsed light in subjects with mild-to-moderate facial photodamage. Design: Six-month, open-label, single-center, pilot study comprising three study treatments, each separated by 30 days, and two follow-up visits (one and four months following third treatment). Setting: Tennessee Clinical Research Center, Nashville, Tennessee. Participants: Ten women (ages 36 to 64 years) with skin color classified as Fitzpatrick I to III. Measurements: The investigator evaluated erythema, dryness, bruising, crusts and erosions, and stinging/burning immediately before and after each treatment and at each follow-up visit. In addition, the investigator rated cosmetic appearance at each follow-up visit. Subjects rated stinging, tingling, itching, and burning 15 minutes after each treatment and cosmetic effects (radiance, smoothness, pore appearance, evenness of skin tone, and overall effect) at each follow-up visit. Results: Mean (standard error of the mean) objective cosmetic appearance scores were 0.900 (0.233) and 1.400 (0.267) (0=very much improved; l=much improved; 2=improved) one and four months following treatment, respectively. Mean subjective assessments of radiance, smoothness, pore appearance, evenness of skin tone, and overall effect ranged from 2.200 to 2.800 (2=much improved; 3=improved) one and four months following treatment. Mean objective erythema, dryness, bruising, and stinging/burning scores were <1 (minimal/slight) at all time points. Mean subjective post-treatment stinging, tingling, itching, and burning scores were <1 (mild) at all time points. Conclusion: Photodynamic therapy with hexyl aminolevulinate and intense pulsed light improved cosmetic appearance and was generally well tolerated. Further investigation in larger patient populations is warranted.Visible changes in skin appearance resulting from sun exposure (ultraviolet [UV] light) are common among adults and include sagging skin, wrinkles, and changes in skin color and texture.1 Many adults with such photoaging seek the restoration of a more youthful appearance; therefore, there is a great demand for cosmetic procedures, particularly those that are noninvasive and well tolerated. Statistics compiled by the American Society of Plastic Surgeons indicate that more than 12.2 million minimally invasive cosmetic procedures were performed in the United States in 2011, predominantly botulinum toxin, dermal fillers, and laser hair removal.2 Most of the reported procedures (10.7 million [88%]) were performed on women.2Intense pulsed light (IPL) therapy is one of several nonsurgical procedures used for the treatment of facial photodamage. IPL utilizes high-intensity (nonlaser) light sources to produce broad-spectrum light wavelength pulses over relatively large treatment areas.3 Energy absorbed by chromophores in the dermis results in selective photothermolysis, sparing surrounding nonpigmented tissue. The utility of IPL for the treatment of photodamage was first established in 2000 in a study in which subjects who underwent four to six full-face IPL treatments (Vasculight, ESC/Sharplan, Norwood, Massachusetts; 500-1200nm wavelength and fluence of 30-50 J/cm²) at three-week intervals demonstrated visible improvement in all aspects of photoaging, including fine wrinkles, irregular pigmentation, skin texture, pore size, and telangiectasias.4 Since that time, numerous clinical studies have provided additional evidence of the beneficial effects of IPL on wrinkles, skin texture, telangiectasias, pigmentation, and collagen formation.3,5-7 Observed beneficial effects in photodamaged skin are believed to reflect contracture of collagen fibers (improved skin texture), increased synthesis of extracellular matrix proteins (increased dermal volume), and increased collagen I, collagen III, and elastin synthesis.3 Damage to nontargeted surrounding tissue is generally limited.3Aminolevulinic acid (ALA) and methyl aminolevulinate (MAL) are topical photosensitizers that have been evaluated in combination with various light sources, including IPL.8-13 Studies evaluating safety and efficacy of these agents in combination with blue or red light have demonstrated cosmetic benefits in subjects with photodamaged skin8,10; however, phototoxicity limits use in some patients.8,10In several small split-face studies, the application of ALA prior to IPL therapy was associated with greater improvement in photodamage parameters (e.g., crow’s feet, tactile skin roughness, mottled hyperpigmentation, telangiectasias, and actinic keratoses) compared with IPL alone, with minimal impact on tolerability.11-13Hexyl aminolevulinate (HAL) is an ester of ALA that has demonstrated cosmetic benefits and minimal side effects when used in combination with red or blue light in adults with visible signs of aging and photodamage.14,15 The objective of the current six-month pilot study was to assess the effects of photodynamic therapy with HAL and IPL in subjects with mild-to-moderate facial photodamage.     

308nm准分子激光联合0.1%糠酸莫米松乳膏治疗面部白癜风疗效观察

目的:探讨308nm准分子激光联合0.1%糠酸莫米松乳膏治疗面部白癜风的疗效及安全性。方法:选取门诊面部白癜风患者180例,随机平均分为三组,共有167例完成了试验观察,A组为治疗组57例,308nm准分子激光(2次/周)联合0.1%糠酸莫米松乳膏(1次/天)治疗;B组为对照1组56例,单用308nm准分子激光治疗(2次/周);C组为对照2组54例,单用0.1%糠酸莫米松乳膏外用治疗(1次/天),疗程均为12周或至皮损完全复色,观察三组治疗方法治疗面部白癜风的疗效及不良反应。结果:A组显效率为75.43%,B组为48.21%,C组为14.81%,A组和B组及C组比较,显效率差异有统计学意义(P<0.05)。三组患者均未出现严重不良反应。结论:308nm准分子激光联合0.1%糠酸莫米松乳膏治疗面部白癜风疗效好、副作用少,显效率明显高于单独治疗。     

吡美莫司乳膏治疗面部脂溢性皮炎疗效观察

目的：评价吡美莫司乳膏治疗面部脂溢性皮炎的有效性和安全性。方法：应用1％吡美莫司软膏治疗面部脂溢性皮炎患者58例,每天2次,疗程4周,于治疗前及治疗后的第1、2、4周各随诊一次。对临床疗效、不良反应、患者及医生的评估进行总结,并于疗程结束后对所有患者进行了2～4周的电话随访。结果：吡美莫司乳膏可以迅速缓解面部脂溢性皮炎的临床症状,由治疗前的（11．17±2．63）分下降至治疗1周后的（6．39±1．83）分,2周后的（5．67±1．85）分,4周后的（4．00±1．61）分,近期临床效果满意,不良反应发生率低。电话随访结果示复发者主要为症状未完全缓解的间断用药者。结论：吡美莫司乳膏用于治疗面部脂溢性皮炎疗效明显,安全性高。     

Treatment of xerosis with a topical formulation containing glyceryl glucoside, natural moisturizing factors, and ceramide

Objective: To assess the effects of Light Formulation, an oil-in-water emulsion, and Rich Formulation, a water-in-oil emulsion, for the treatment of xerosis. Design: Two double-blind, vehicle-controlled trials (both formulations); a double-blind, randomized regression study (Rich Formulation); and a single-blind tolerability study (Light Formulation). The two formulations were applied twice daily for two weeks, for five days in the regression study, and twice daily for two weeks in the tolerability study. Setting: Studies were conducted during winter in Hamburg, Germany. Participants: A total of 169 subjects were enrolled and 154 completed the studies. The majority were between 50 and 80 years of age, women, all with very dry skin. One withdrew because of an incompatibility reaction that reoccurred with the subject's own body lotion after sun exposure. Measurements: Skin hydration and skin barrier function with both formulations over two weeks, long-term moisturization effect after discontinuation of Rich Formulation, and symptom improvement and skin tolerability with Light Formulation. Results: Vehicle-controlled studies of Light and Rich Formulations demonstrated significantly improved hydration at Weeks 1 and 2 versus the untreated site and vehicles, and significantly reduced transepidermal water loss versus untreated site and basic vehicle. Both products significantly decreased visible dryness and tactile roughness. In the regression study, Rich Formulation maintained significant moisturization six days after treatment discontinuation. Light Formulation reduced symptoms of itching, burning, tightness, tingling, and feeling of dryness. Conclusion: These formulations represent a new approach for the treatment of xerosis by addressing multiple key deficiencies in skin hydration.     

Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel for the Treatment of Acne Vulgaris: Which Patients are Most Likely to Benefit the Most?

Clindamycin phosphate 1.2%/tretinoin 0.025% gel is a topical combination formulation used once daily for the treatment of acne vulgaris, with approval in the United States for patients >12 years of age. Three 12-week, randomized, vehicle-controlled, pivotal trials included > 1,800 actively treated subjects. In addition, an open-label, 52-week study was also completed with 442 subjects enrolled. The skin tolerability, safety, and efficacy of clindamycin phosphate 1.2%/tretinoin 0.025% gel applied once daily is well-established based on data from pivotal studies and analyses in other subsequent publications including from pooled analysis of results from 4,550 subjects. This article discusses results from the pivotal 12-week, Phase 3 studies of clindamycin phosphate 1.2%/tretinoin 0.025% gel applied once daily in 845 subjects with mild, moderate, or severe facial acne vulgaris and differentiates patterns of therapeutic response using study endpoint successes defined as clear, almost clear, or at least a 2-grade improvement in the AV severity rating.Clindamycin phosphate 1.2%/tretinoin 0.025% gel (ClinP/Tret; Ziana gel, Valeant Pharmaceuticals) is a combination topical formulation that was approved by the United States Food and Drug Administration (FDA) in 2006 and is indicated for “the topical treatment of acne vulgaris in patients 12 years or older”.1 Study enrollment included subjects with facial acne vulgaris (AV) who were graded as mild, moderate, or severe based on criteria specified in the study protocol.1,2 FDA approval included evaluation of three prospective, multicenter, randomized controlled trials (RCTs). Two of these pivotal trials followed identical study protocols, with comparison of ClinP/Tret gel versus each of the individual active ingredients and vehicle. In these two pivotal RCTs, ClinP/Tret gel (n=845) applied once daily proved to be superior in efficacy to tretinoin 0.025% (n=846), clindamycin phosphate 1.2% (n=426), and vehicle (n=423) and also demonstrated favorable skin tolerability and safety in subjects with facial AV graded as mild, moderate, or severe.1,2 In the third RCT, ClinP/Tret gel (n=1008) proved to be superior to clindamycin phosphate 1.2% (n=1002) in efficacy, with favorable skin tolerability and safety also reconfirmed, in subjects with facial AV graded as moderate or severe.1,2In addition to the published data from the pivotal RCTs, additional research has demonstrated other clinically relevant findings related to the use of ClinP/Tret gel for treatment of facial AV. ClinP/Tret gel has been used effectively in combination with a benzoyl peroxide cloth formulation, an observation that is important due to concerns related to emergence of clindamycin-resistant strains of Propionibacterium acnes.3 A RCT study (N=33) in subjects ≥12 years of age with Fitzpatrick skin type IV to VI demonstrated that ClinP/Tret gel applied once daily was effective and well-tolerated for treatment of facial AV of mild to moderate severity in patients with skin of color (dark skin).4 A randomized, evaluator-blinded, split-face, 21-day study reported that ClinP/Tret gel (n=45) was better tolerated than tretinoin microsphere gel 0.1% (n=23), with outcomes demonstrating significantly reduced erythema (P<0.04), scaling (P<0.03), itching (P<0.02), burning (P<0.03), and stinging (P<0.04) with use of ClinP/Tret gel; trends for greater erythema, scaling, and subjective discomfort for 0.1% adapalene gel as compared to ClinP/Tret gel were noted, however, these differences were not statistically significant.5 Lastly, following designated protocols for irradiation with ultraviolet (UV) light exposure (UVA, UVB) and visible light, ClinP/Tret gel demonstrated a low potential for phototoxicity (n=37) and photoallergenicity (n=58).6This article evaluates results from Phase 3 RCTs of ClinP/Tret gel applied once daily for 12 weeks in 845 study subjects with mild, moderate, or sever facial AV. The objective of this analysis is to differentiate patterns of therapeutic response using study endpoint successes (often referred to as treatment success in clinical trials) defined in the study protocol as clear, almost clear, or at least a 2-grade improvement in AV severity rating.