Clinical and histological evaluation of 1% nadifloxacin cream in the treatment of acne vulgaris in Korean patients

Objectives Nadifloxacin is a fluoroquinolone with broad‐spectrum antibacterial activity. Although it is used as an acne treatment in some European countries, it has not been used to treat Korean acne patients. We aimed to evaluate the clinical efficacy and safety of 1% nadifloxacin cream and the histological changes it incurs when used to treat mild to moderate facial acne in Korean patients. Methods An eight‐week, randomized, prospective, split‐face, double‐blind, vehicle‐controlled trial was performed. All participants were treated with 1% nadifloxacin cream on one‐half of the face and vehicle cream on the other, twice per day for eight weeks. Results At final visits, inflammatory acne lesions were reduced by 70% on nadifloxacin‐treated skin and increased by 13.5% on vehicle‐treated skin; non‐inflammatory acne lesions showed reductions of 48.1 and 10.1%, respectively. A significant difference was observed between the two treatments at four weeks. Histopathological examinations of the acne lesions showed decreased inflammation and interleukin‐8 expression but no change in transforming growth factor‐β expression in nadifloxacin‐treated skin compared with vehicle‐treated skin after eight weeks of treatment. Conclusions Nadifloxacin 1% cream is an effective, safe, and well‐tolerated topical treatment for Korean patients with mild to moderate acne vulgaris. Histopathological changes after nadifloxacin treatment were well correlated with clinical outcomes. Therefore, nadifloxacin can be used as an effective and safe treatment option in the management of mild to moderate acne in Asian subjects.     

Photodynamic therapy of acne vulgaris using 5‐aminolevulinic acid 0.5% liposomal spray and intense pulsed light in combination with topical keratolytic agents

Background Increasing antibiotic resistance of Propionibacterium acnes and growing awareness on the side effects of topical and systemic drugs in the treatment of acne vulgaris by physicians and patients have paved the way for a search into new efficacious and safe treatment modalities such as photodynamic therapy (PDT). Although the efficacy of PDT using 20% 5‐aminolevulinic acid (ALA) cream has been established, phototoxic side effects limit its use. The 5‐ALA concentration can be lowered by a factor of 40 by changing the vehicle of 5‐ALA from a moisturizing cream to liposome encapsulation. Objectives Assessment of the efficacy and the safety of PDT using 5‐ALA 0.5% in liposomal spray and intense pulsed light (IPL) in combination with topical peeling agents (Li‐PDT‐PC) in acne vulgaris. Materials and Methods 32 patients suffering from acne participated in this randomized, prospective, single blind study. All patients were treated with Li‐PDT‐PC. During the study nine patients were additionally treated with topical or systemic antibiotics (Li‐PDT‐PC‐AT). These patients were removed from the study although their results were recorded. Results After a mean period of 7.8 months and a mean number of 5.7 treatments the mean total number of lesions dropped from 34.6 lesions to 11.0 lesions, resulting in a mean improvement of 68.2%. Side effects were minimal. Additionally, an intention to treat analysis was conducted. Conclusion Photodynamic therapy of acne vulgaris using 5‐ALA 0.5% liposomal spray and IPL in combination with topical peeling agents is safe and efficacious, even in patients with acne recalcitrant to standard therapy.     

Topical retinoyl beta-glucuronide is an effective treatment of mild to moderate acne vulgaris in Asian-Indian patients.

Topical retinoyl beta-glucuronide (RBG) is beneficial in the treatment of mild to moderate acne (acne vulgaris) in patients largely of North-European origin in the US. Because the skin types of people in India are different from those in the US, we investigated the effectiveness and toxicity of topical RBG in acne patients in India. Each day, 27 acne patients were treated topically with the vehicle, and 39 acne patients were treated topically with 0. 16% RBG cream for 18 weeks in a double-blind study. A significant reduction (p < 0.001) in total lesions, inflammatory lesions and noninflammatory lesions in patients treated with RBG as compared with the vehicle only (86.8, 80.2 and 94.6% vs. 40.1, 34.3 and 50%, respectively) was observed. No side effects were associated with topical RBG treatment. Thus, topical 0.16% RBG is a rapid, effective and nontoxic treatment for mild to moderate acne in Asian-Indian patients.     

Beneficial effects of the melanocortin analogue Nle4‐D‐Phe7‐α‐MSH in acne vulgaris

Background α‐Melanocyte‐stimulating hormone (α‐MSH) is a melanocortin peptide that increases skin pigmentation during ultraviolet light‐mediated tanning. As α‐MSH has been shown to possess anti‐inflammatory effects, we assessed the clinical potential of a superpotent α‐MSH analogue, afamelanotide (Nle⁴‐d ‐Phe⁷‐α‐MSH), in patients with acne vulgaris, the most common inflammatory skin disorder. Methods Afamelanotide (16 mg) was given in a phase II open‐label pilot study subcutaneously as a sustained‐release resorbable implant formulation to 3 patients with mild‐to‐moderate facial acne vulgaris. Evaluation included lesion count, adverse effects and patient‐reported outcome. Monitoring of laboratory parameters included differential blood counts, electrolytes, urine analysis, and liver and kidney function tests. Skin melanin density was measured by reflectance spectrophotometry. Results The total number as well as the number of inflammatory acne lesions declined in all patients 56 days after the first injection of afamelanotide. Life quality as measured by Dermatology Life Quality Index likewise improved in all 3 patients 56 days after the first injection of afamelanotide. There were no adverse effects except mild and short‐term fatigue in one patient. All patients experienced increased pigmentation especially on the face. Clinically relevant changes in laboratory parameters were not detected. Conclusions Afamelanotide appears to have anti‐inflammatory effects in patients with mild‐to‐moderate acne vulgaris. Future trials are needed to confirm the anti‐inflammatory action of this melanocortin analogue in patients with acne vulgaris.     

Topical retinoids in acne – an evidence‐based overview

Topical retinoids are important tools in the management of acne because they act against comedones and microcomedones and have direct anti‐inflammatory effects. The substances approved for acne treatment comprise tretinoin (all‐trans‐retinoic acid),isotretinoin (13‐cis retinoic acid) as well as the synthetic third‐generation polyaromatic retinoids adapalene and tazarotene,the latter being approved for acne treatment in the US only.Retinaldehyde is used in cosmetic preparations against acne. All topical retinoids are effective as single agents in mild to moderate acne but differ in efficacy and tolerability. Tazarotene 0.1% is more effective than tretinoin 0.025% or 0.1% microsphere gel or adapalene 0.1% gel or cream (EBM‐level 2c). Adapalene 0.1% is equally effective to tretinoin 0.025% or tretinoin microsphere 0.1% gel or tretinoin 0.05% cream or isotretinoin 0.05% gel (EBM‐level 2c). Adapalene 0.1% gel is significantly better tolerated than tazarotene 0.1% gel, tretinoin 0.025% and tretinoin 0.05% gel, tretinoin 0.05% cream,tretinoin microsphere 0.1% gel or isotretinoin 0.05% gel (EBM‐level 2c).The safety profile of topical retinoids differs from their systemic counterparts and is related mainly to local adverse effects, such as erythema, dry‐ness,itching and stinging.The currently available evidence justifies the use of topical retinoids in most types of acne and during maintenance treatment.     

15 % Azelainsäuregel in der Behandlung der Akne. Zwei doppelblinde klinische Vergleichsstudien

Background: Topical measures are still the mainstay in the therapy of mild‐to‐moderate acne vulgaris. Azelaic acid 20 % in a cream formulation has been established as an efficacious and safe topical drug for 15 years. A new non‐alcoholic hydrogel formulation containing 15 % azelaic acid was clinically tested against two standard drugs – 5 % benzoyl peroxide (BPO) and 1 % clindamycin. Patients and Methods: In two independent, randomized, blinded comparative trials 15 % azelaic acid gel was clinically tested against 5 % benzoyl peroxide (BPO) gel in 351 patients and against 1 % clindamycin gel in 229 patients. The drugs were applied b. i. d. for 4 months. Results: Azelaic acid 15 % gel proved to be as effective as BPO and clindamycin with median % reduction of the inflamed lesion (papules and pustules) of 70 %, and 71 % respectively. The azelaic acid gel was well‐tolerated, the side effects (local burning and irritation) were distinctly less than with BPO but more pronounced than with clindamycin. Despite these side effects, the treatment was well‐accepted by the majority of patients. Conclusions: Azelaic acid gel is an effective topical monotherapy for mild‐to‐moderate acne vulgaris; its new gel form is an enrichment of acne therapy.     

Topical taurine bromamine, a new candidate in the treatment of moderate inflammatory acne vulgaris: a pilot study

Taurine bromamine (TauBr), the product of taurine and hypobromous acid (HOBr), exerts anti-inflammatory and antibacterial properties. Recently we have shown that Propionibacterium acnes, a potential pathogenic agent of acne, is extremely sensitive to TauBr. As topical antibiotics are associated with the emergence of resistant bacteria, TauBr seems to be a good candidate for topical therapy for acne vulgaris. In our double blind investigation, the efficacy and safety of 3.5 mM TauBr cream was evaluated. 1% Clindamycin gel (Clindacin T), one of the most common topical agents in the treatment of acne vulgaris, was used as a control. Forty patients with mild to moderate inflammatory facial acne vulgaris were randomly treated with either TauBr or clindamycin for 6 weeks, twice-a-day. More than 80% of the patients markedly improved with both treatments, without any adverse effects observed. Both TauBr and clindamycin produced a significant reduction in inflammatory skin lesion counts (papules/ pustules). After 6 weeks, comparable reductions of acne lesions, 65% and 68%, were observed in the TauBr and clindamycin groups, respectively. In conclusion, these data support our concept that TauBr can be used as a topical agent in the treatment of acne vulgaris, especially in patients who have already developed antibiotic resistance.     

The clinical and histological effect of home‐use,combination blue–red LED phototherapy for mild‐to‐moderate acne vulgaris in Korean patients: a double‐blind,randomized controlled trial

Background Blue and red light have been reported to have beneficial effects on acne. However, there has been no double‐blind, randomized study of acne treatment for combined blue and red light‐emitting diode (LED) devices, and the associated molecular mechanisms have rarely been investigated. Objectives To evaluate the efficacy, safety and histological changes of combined blue and red LED phototherapy for acne vulgaris. Methods Thirty‐five patients with mild‐to‐moderate acne were randomly assigned to either a home‐use irradiation group using an LED device, or a control group using a sham device. The treatment group was instructed to serially irradiate their forehead and cheeks with 420‐nm blue light and 660‐nm red light for 2·5 min twice daily for 4 weeks. Results At the final visit at 12 weeks, both inflammatory and noninflammatory acne lesions had decreased significantly, by 77% and 54%, respectively, in the treatment group. No significant difference was observed in the control group. In the treatment group, sebum output reduction, attenuated inflammatory cell infiltrations and a decreased size of the sebaceous gland were found. The immunostaining intensities for interleukin (IL)‐8, IL‐1α, matrix metalloproteinase‐9, toll‐like receptor‐2, nuclear factor‐κB, insulin‐like growth factor‐1 receptor and sterol response element binding protein (SREBP)‐1 were reduced concomitantly. Messenger RNA expression of SREBP‐1c was also decreased. No severe adverse reactions were reported. Conclusions This LED phototherapy was safe and effective for treating not only inflammatory but also noninflammatory acne lesions, with good compliance. The experimental results correlated well with clinical results, partly elucidating the related molecular mechanisms.     

An observational study of methionine‐bound zinc with antioxidants for mild to moderate acne vulgaris

APC is a novel methionine‐based zinc complex with antioxidants that has been used in acne as a nutritional supplement. This is based on the proven role of zinc and antioxidants in improving acne, specially the inflammatory lesions. The objectives of this study are to explore the efficacy, safety, and tolerability of APC in acne patients with mild to moderate facial acne vulgaris. In this exploratory trial, 48 patients were treated with oral APC thrice a day for 3 months followed by a 4‐week treatment‐free period. At the end of treatment (Week 12), there was a statistically significant improvement in the global acne count (p < 0.05), which began after 8 weeks (p < 0.05). Almost 79% (38/48) of the patients had 80–100% improvement. There was a significant reduction in pustules (8 weeks (p < 0.05) and 12 weeks (p < 0.001)), and papules and closed comedones (8 weeks (p < 0.05) and 12 weeks (p < 0.001)). Only two patients had side effects. The current data indicate that treatment with oral APC thrice daily for 12 weeks in patients with mild to moderate facial acne vulgaris is efficacious and well tolerated. As the onset of action is late, concomitant topical therapy can enhance the results.     

Topical nadifloxacin 1% cream vs. topical erythromycin 4% gel in the treatment of mild to moderate acne

Topical antibiotics are the mainstay of therapy in mild to moderate inflammatory acne. Topical erythromycin is one of the most common prescribed topical antibiotics. Nadifloxacin, another topical antibiotic for acne, was recently introduced into the market in our country. In this study, we compared the efficacies and safety of topical nadifloxacin 1% cream and erythromycin 4% gel in acne. A total of 86 patients with mild to moderate facial acne were randomized into two treatment groups. The efficacies of the drugs were assessed by lesion counts. An acne severity index (ASI) was also calculated. In both groups, there was a significant reduction in lesion counts and ASI scores beginning from the first visit at week 4. This reduction continued throughout the 12-week study period. Both treatments were well tolerated. We conclude that when topically applied, both nadifloxacin 1% cream and erythromycin 4% gel are equally effective and safe treatments for mild to moderate facial acne.     

5-氨基酮戊酸光动力疗法治疗寻常痤疮临床应用研究

目的 探索5-氨基酮戊酸光动力疗法(ALA-PDT)治疗寻常痤疮的ALA最适浓度和最佳敷药时间.方法 将30例中、重度寻常痤疮患者随机分为两组,第一组15例,给以10%ALA乳膏外敷,分别在不同时间点(1、2、3、4、5 h)和不同皮损进行原卟啉Ⅸ(PpⅨ)荧光光动力诊断和皮损组织PpⅨ荧光采集与定量分析;第二组15例,在每例患者的右侧面颊、左侧面颊、前额的痤疮皮损上分别给以3%、5%、10%ALA乳膏外敷3 h后进行PpⅨ荧光光动力诊断和荧光定量研究;同时对该组患者不同部位采用不同浓度ALA-PDT的疗效和不良反应进行临床研究.结果 第一组痤疮患者经10%ALA乳膏外敷,暗室环境下采用激发光源照射皮损后发现,炎性丘疹、脓疱和囊肿均显示PpⅨ强砖红色荧光;粉刺、炎性丘疹、脓疱和囊肿的PpⅨ荧光强度分别为1.3、4.3,5.1和5.8校准单位,PpⅨ荧光强度随着皮损严重程度的增加而增强;同时,随着外敷时间的延长,PpⅨ荧光强度逐渐增强,敷药3 h,4 h、5 h时PpⅨ荧光强度明显高于1 h和2 h(P<0.05).第二组患者不同部位采用3%、5%、10%ALA封包3 h,其相同皮损内PpⅨ荧光强度差异无统计学意义(P>0.05);分别以3%、5%、10%ALA乳膏外涂于15例患者右侧面颊、左侧面颊、前额部位,经过两次ALA-PDT治疗后,痊愈5例、显效6例,总有效率为73%;每例患者的不同部位皮损之间,疗效改善情况无明显差异.副作用表现为轻至中度的红斑、肿胀,严重时少许渗出,仅2例出现暂时性色素沉着,所有病例均未出现溃疡和瘢痕等严重不良反应.结论 ALA-PDT适用于以炎性丘疹、脓疱和囊肿为主要表现的寻常痤疮治疗,宜采用3%ALA浓度和3 h敷药时间.     

Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: A double‐blind,randomized placebo‐controlled trial

The emergence of bacterial resistance is a global crisis. Prolonged use of antibiotics especially in acne is one issue of concern among dermatologists. Ketoconazole (KTZ) cream, a topical antifungal with anti‐inflammatory and antiandrogenic actions, can decrease lipase activity of Cutibacterium acnes in vitro. We evaluated the efficacy and safety of KTZ cream in mild adult female acne (AFA) by conducting a randomized, double‐blind, placebo‐controlled trial using KTZ 2% and placebo cream twice daily for 10 weeks. We assessed the improvement of clinical severity, measured by AFA score graded by investigators and participants, and the change of acne count. Forty‐one participants enrolled in our study. The proportion of participants with acne improvement from baseline (42.9% vs 9.5%, P = 0.015) and the success rate (45.0% vs 14.3%, P = 0.043) in the KTZ group were significantly higher than that of the placebo group. The most common adverse events were dryness and itching. The percentage change of acne count decreased significantly compared with baseline but did not differ statistically between the two groups (P = 0.268). We concluded that the KTZ monotherapy showed a plausible effect in improving AFA with excellent safety profile. It should be considered as a viable option for mild AFA treatment.     

Cortexolone 17α-propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0·05% cream

Background Acne vulgaris is a disorder of the pilosebaceous unit in which the androgens contribute to its onset and persistence. The use of antiandrogens is therefore potentially effective; however, antiandrogens for topical use are not available on the market. Cortexolone 17α‐propionate (CB‐03‐01; Cosmo S.p.A, Lainate, Italy) is a new potent topical antiandrogen potentially useful in acne vulgaris. Objectives To evaluate the safety and the topical efficacy of CB‐03‐01 1% cream in acne vulgaris as compared with placebo and with tretinoin 0·05% cream (Retin‐A^®; Janssen‐Cilag). Methods Seventy‐seven men with facial acne scored 2–3 according to Investigator’s Global Assessment (IGA) were randomized to receive placebo cream (n = 15), or CB‐03‐01 1% cream (n = 30), or tretinoin 0·05% cream (n = 32) once a day at bedtime for 8 weeks. Clinical efficacy was evaluated every 2 weeks including total lesion count (TLC), inflammatory lesion count (ILC), acne severity index (ASI) and IGA. Safety assessment included local irritancy score, laboratory tests, physical examination, vital signs and recording of adverse events. Results CB‐03‐01 1% cream was very well tolerated, and was significantly better than placebo regarding TLC (P = 0·0017), ILC (P = 0·0134) and ASI (P = 0·0090), and also clinically more effective than comparator. The product also induced a faster attainment of 50% improvement in all the above parameters. Conclusions This pilot study supports the rationale for the use of topical antiandrogens in the treatment of acne vulgaris. CB‐03‐01 1% cream seems to fit with the profile of an ideal antiandrogen for topical use.     

Oral Isotretinoin for the treatment of Aripiprazol‐induced acneiform rash

Acneiform rash is a commonly reported side effect to certain types of medications, including antipsychotic agents. Its clinical presentation consists mainly of papulopustular lesions. Other types of lesions, such as nodular or cystic, can also be observed. Body distribution of the lesions follows a similar pattern to acne vulgaris. Depending on the severity of the case, drug‐induced acne may be treated in different ways. In mild cases, the use of topical antibiotics and retinoids in combination is usually effective. With more severe forms, it may be necessary to add oral antibiotics, such as tetracyclines, but a good response is not always achieved. Identification of the drug responsible for the side‐effect is mandatory in refractory eruptions. Herein, we present the case of an Aripiprazole‐induced acneiform rash successfully treated with oral Isotretinoin. The treatment was effective and well tolerated and there was no need to discontinue the psychopharmacological medication. This is the first study to report this modality of treatment.     

Open‐label,randomized, multicenter,phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long‐term use in patients with acne vulgaris: A secondary publication

An open‐label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long‐term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non‐inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end‐point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non‐inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long‐term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long‐term treatment of patients with acne vulgaris.     

Gold nanoshell‐mediated photothermal therapy for acne vulgaris

Acne vulgaris, a common and chronic disorder of the pilosebaceous unit, affects up to 85% of adolescent and young adults. Although the current treatment options are effective, they are associated with unwanted side effects, chronicity, relapses, and recurrences. Recently, the Food and Drug Administration approved topical application of gold microparticles for selective photothermolysis to treat acne vulgaris. Here, we report two cases showing the efficacy of gold nanoshell‐mediated photothermal therapy for recurrent acne that were refractory to previous treatments. In both cases, three sessions of photothermal therapy prevented the development of new lesions during a follow‐up period of 3–4 months without causing any adverse effects. The two cases reported here demonstrate the possibility of gold nanoshell‐mediated photothermal therapy as a safe and effective treatment for recurrent acne vulgaris in Asian patients.     

Efficacy of combined topical treatment of acne vulgaris with adapalene and nadifloxacin: a randomized study

Topical retinoid and antibiotic combination therapy is an integral part of acne treatment and is considered the appropriate first-line therapy according to the Japanese guideline for moderate and severe acne. In this combination, clindamycin or doxycycline are mostly used as antibiotics, but there have been no reports on the effectiveness of nadifloxacin, a widely used antibiotic in Japan and European countries for acne, in combination with topical retinoid. To confirm the efficacy and safety of adapalene gel and nadifloxacin cream in the treatment of Japanese patients with acne vulgaris, a total of 50 patients were randomized to the two groups, the combination therapy and the adapalene monotherapy, and each therapy was tested for 8 weeks. The percentage reduction in the number of inflammatory acne lesions was evaluated and the safety was monitored through adverse events. The combination of adapalene gel and nadifloxacin cream produced a significantly higher reduction in the inflammatory lesions at 2 weeks (P = 0.047) and at 8 weeks (P = 0.011) after the starting than did adapalene gel monotherapy. The combination did not elevate the side effects of erythema and scale scores, but rather significantly depressed erythema at 1 week. This study showed the efficacy and safety of the combination therapy of nadifloxacin cream with adapalene gel for the inflammatory acne.     

A randomized,double‐blind,placebo‐controlled trial to determine the efficacy and safety of lactoferrin with vitamin E and zinc as an oral therapy for mild to moderate acne vulgaris

Lactoferrin is an iron‐binding milk‐derived protein that has shown antibacterial and anti‐inflammatory effects in vitro and in vivo. The objective of this study was to determine the efficacy and safety of lactoferrin, combined with vitamin E and zinc, for mild to moderate acne vulgaris. In this randomized, double‐blind, placebo‐controlled trial, 168 subjects aged 13–40 years old were randomly assigned to take either a capsule formulation containing lactoferrin with vitamin E and zinc or placebo twice a day for 3 months. The primary outcome measure was a reduction in the number of acne lesions compared to placebo. A total of 164 subjects completed the study per protocol. The lactoferrin group (n = 82) showed a significant median percent reduction in total lesions as early as 2 weeks (14.5%, P = 0.0120), with the maximum reduction occurring at week 10 (28.5%, P < 0.0001) compared to placebo group (n = 82). Maximum reduction in comedones (32.5%, P < 0.0001) and inflammatory lesions (44%, P < 0.0001) was also seen at week 10 compared to placebo. Sebum scores were improved by week 12. No adverse events were observed during the trial. A twice daily regimen of lactoferrin with vitamin E and zinc significantly reduced acne lesions in people with mild to moderate acne vulgaris.     

复方多黏菌素B软膏治疗寻常痤疮临床疗效观察

目的观察复方多黏菌素B软膏治疗寻常痤疮的疗效及安全性。方法将156例寻常痤疮患者分为两组,试验组外用复方多黏菌素B软膏每日2次,对照组外用5%过氧苯甲酰凝胶每日2次,疗程均为4周。结果试验组患者经治疗4周后皮损数量明显较治疗前减少,与对照组相比差异有统计学意义(P<0.05);皮损消退显效率两组无明显差异(P>0.05);不良反应发生率试验组低于对照组(P<0.05)。结论复方多黏菌素B软膏治疗Ⅰ、Ⅱ级寻常痤疮有效,且不良反应少。     

Simplifying regimens promotes greater adherence and outcomes with topical acne medications: a randomized controlled trial

New combination topical formulations for the treatment of acne may improve outcomes by increasing adherence. We assessed adherence to and efficacy of a combination topical medication for acne applied once daily compared with daily applications of 2 separate generic subcomponents. Twenty-six participants with mild to moderate acne vulgaris were randomized to 12 weeks of once daily application of clindamycin phosphate 7.2%-tretinoin 0.025% gel (CTG) combination product or separate daily applications of clindamycin phosphate gel 1% and tretinoin cream 0.025% (C gel + T cream) for a total of 2 applications daily. Disease severity was measured at baseline and weeks 4, 8, and 12. Adherence was monitored using electronic monitoring caps on the medication tubes. Of the 26 participants enrolled, 21 completed the 12-week study. Median adherence in the CTG group was 88% compared with 61% in the C gel + T cream group. There was a 51% mean reduction in total lesions for the CTG group versus a 32% mean reduction for the C gel + T cream group by the end of the study. Both CTG and separate applications of C gel + T cream improved mild to moderate acne. The use of a once daily combination product has the advantage of promoting better adherence and clinical outcomes.