Topical Polyphenon E in the treatment of external genital and perianal warts: a randomized controlled trial

Background Benign external genital and perianal warts (condylomata acuminata) are disfiguring, displeasing skin tumours caused by human papillomavirus that may vitally burden affected patients and their partners. Current treatment options are still unsatisfactory due to low efficacy, high recurrence rates or an unfavourable side‐effect profile. Although most recently prophylactic vaccines have been recommended for adolescent women, appropriate treatment modalities for anogenital warts are still needed. Green tea catechins exert antiviral, antioxidative, antiproliferative and immunostimulatory activity. Polyphenon^® E (MediGene AG, Munich, Germany), a proprietary extract of green tea leaves, was therefore investigated for the topical treatment of this frequent viral disease. Objectives To investigate Polyphenon^® E 15% and 10% ointment for efficacy and safety in the treatment of anogenital warts in immunocompetent men and women. Methods Five hundred and three patients were randomized to receive either Polyphenon^® E 15% or 10% ointment or matching vehicle. The topical treatment was self‐applied by the patients three times daily to all warts. Assessment of response and of adverse events was performed biweekly until complete clearance of all (baseline and new) anogenital warts or for up to 16 weeks. Recurrence was evaluated during a 12‐week treatment‐free follow‐up period for patients with complete clearance. Results About 53% of patients treated with Polyphenon^® E 15% ointment showed complete clearance of all baseline and new anogenital warts, 51% for Polyphenon^® E 10% ointment, and 37% for vehicle (P = 0·01 and P = 0·03, respectively; two‐sided Fisher’s exact test; intent‐to‐treat population, last observation carried forward analysis). Women responded better than men, with about 60% of women and 45% of men in both active groups achieving complete clearance of all warts. Time to complete clearance was comparable for both strengths of Polyphenon^® E ointment. About 78% of all patients treated with either Polyphenon^® E 15% or 10% ointment showed wart clearance rates of 50% or better. Less than 6% and 4% of patients in the Polyphenon^® E 15% and 10% ointment groups experienced wart recurrence during follow‐up. Polyphenon^® E ointments demonstrated a good safety profile with the majority of all adverse events being local application site reactions assessed as mild or moderate. Local reactions declined during continued treatment. Conclusions The results indicate that Polyphenon^® E ointment is an efficacious and safe patient‐applied topical treatment for external genital and perianal warts. Its use in intra‐anal, intravaginal and cervical condylomas and other intraepithelial lesions warrants further clinical investigation.     

Treatment with a barrier-strengthening moisturizing cream delays relapse of atopic dermatitis: a prospective and randomized controlled clinical trial

Background  Standard treatment of atopic dermatitis (AD) is based on topical glucocorticosteroids or calcineurin inhibitors to treat flares combined with moisturizer treatment to alleviate dry skin symptoms. Patients with AD have an abnormal skin barrier function, and strategies for reducing the risks for eczema would be to repair the barrier or prevent barrier dysfunction.
Objectives  The objective of this study was to explore the time to relapse of eczema during a 26-week maintenance treatment with a urea containing moisturizer compared to no treatment (neither medical nor non-medicated preparations) after successful clearing of atopic lesions. The moisturizer has previously been shown to improve skin barrier function.
Methods  Patients applied betamethasone valerate (0.1%) on eczematous lesions during a 3-week period. Those with cleared eczema entered a 26-week maintenance phase, applying the moisturizer or left the previously affected area untreated. Upon eczema relapse, patients were instructed to contact the clinic and to have the relapse confirmed by the investigator.
Results  Fifty-five patients entered the study and 44 patients were included in the maintenance phase (22 using moisturizer twice daily and 22 using no treatment). Median time to relapse for patients treated with moisturizer was > 180 days (duration of the study) compared with 30 days for the no-treatment group. Sixty-eight per cent of the patients treated with the moisturizer and 32% of the untreated patients remained free from eczema during the observation period.
Conclusions  Maintenance treatment with a barrier-improving urea moisturizer on previous eczematous areas reduced the risk of relapse to approximately one third of that of no treatment.     

A randomized and placebo-controlled study to compare the skin-lightening efficacy and safety of lignin peroxidase cream vs. 2% hydroquinone cream

Background Historically, the most effective treatments for skin lightening have contained hydroquinone. However, there is a need for an effective alternative. Aims The purpose of this study was to evaluate the skin‐lightening efficacy and safety of lignin peroxidase (LIP) creams using a regimen of both day and night products compared with twice‐daily application of 2% hydroquinone cream and placebo in Asian women. Patients/Methods This was a randomized, double‐blind, placebo‐controlled, split‐face, single‐center study of 51 patients. Patients were randomized to receive day and night LIP cream on one randomly selected side of their face and either 2% hydroquinone cream or placebo on the other. Results A statistically significant change from baseline in the melanin index was observed in LIP‐treated skin, with a mean reduction of 7.6% (P < 0.001) on Day 31. Conversely, hydroquinone and placebo did not provide a statistically significant lightening effect when instrumentally measured. Dermatologist scoring demonstrated a significant improvement in overall fairness as early as 8 days after treatment initiation in the LIP‐treated group, which was not observed in the other groups. Overall, patients preferred the LIP creams. Conclusions The application of day/night LIP cream provided a significantly more rapid and observable skin‐lightening effect than hydroquinone 2% cream or placebo.     

Efficacy of topical dimethyl sulfoxide (DMSO) 50% solution vs tretinoin 0.5% cream in treatment of patients with primary macular amyloidosis: A split‐side single‐blinded randomized clinical trial

Primary localized cutaneous amyloidosis (PLCA) is a recalcitrant sporadic dermatological condition and most treatments have failed so far. We studied the efficacy of topical dimethyl sulfoxide (DMSO) 50% solution in comparison with tretinoin 0.5% cream in treatment of macular amyloidosis. In this split‐side within‐person single‐blinded randomized clinical trial, 18 patients with bilateral macular amyloidosis received topical DMSO 50% solution and tretinoin 0.5% cream either on their right or the left side. The colorimetry, pruritus scoring, and photography were done. A significant pigmentation decline per each follow‐up was observed in DMSO group compared to the tretinoin group (tretinoin: ?1.31 vs DMSO: ?7.34; difference in slopes: ?6.03 [95% confidence interval: ?12.06 to ?0.01], P_Interaction = .049). An insignificant diminution trend in pigmentation was observed for both treatments (P_tretinoin = .672, P_DMSO = .092). Also, both treatments relived itchiness, but DMSO completely dispatched itchiness from the first follow‐up (P = .003 for tretinoin and <.0001 for DMSO). In conclusion, our results showed DMSO and tretinoin cream have the positive effect on the both pigmentation and itchiness in PLCA. DMSO may be more beneficial than tretinoin, since DMSO was significantly better in reducing itchiness. More investigations are warranted to provide sufficient evidence.     

0.05%卤米松乳膏治疗皮炎湿疹类皮肤病多中心、随机对照、开放研究

目的观察0.05%卤米松乳膏治疗皮炎湿疹类皮肤病的疗效和安全性,并与0.1%糠酸莫米松乳膏进行比较。方法采用多中心、随机、开放试验,对92例亚急性湿疹和神经性皮炎患者外用0.05%卤米松乳膏或0.1%糠酸莫米松乳膏进行治疗,观察记录患者的临床表现和治疗反应。结果0.05%卤米松乳膏临床疗效优于0.1%糠酸莫米松乳膏,有效率分别为91.3%和71.7%(P<0.05),治疗指数分别为86.79%和74.37%(P<0.05)。结论0.05%卤米松乳膏治疗亚急性湿疹和神经性皮炎效果好,不良反应轻。     

Pimecrolimus cream 1% vs. betamethasone 17-valerate 0.1% cream in the treatment of seborrhoeic dermatitis. A randomized open-label clinical trial

BACKGROUND: Seborrhoeic dermatitis is a chronic inflammatory disease with remissions and exacerbations, characterized by erythema, scaling and pruritus primarily on the face, scalp and chest. Corticosteroids and antifungals are the mainstay of therapy. However, chronic use of corticosteroids is associated with side-effects such as skin atrophy and telangiectasia. Pimecrolimus, an inhibitor of calcineurin, has been used successfully in one patient with seborrhoeic dermatitis. OBJECTIVES: The objective of this randomized open-label clinical trial was to compare the efficacy and tolerability of pimecrolimus in comparison with a potent corticosteroid (betamethasone 17-valerate) in the treatment of seborrhoeic dermatitis. METHODS: Twenty patients with seborrhoeic dermatitis were included in this study, 11 patients in the pimecrolimus 1% cream group and nine patients in the betamethasone 17-valerate 0.1% cream group. Patients were instructed to use a thin layer of the study products twice daily at the lesional area and to discontinue treatment as soon as symptoms were absent. Clinical measures assessed were erythema, scaling and pruritus which were evaluated using a four-point scale (0-3). RESULTS: Both pimecrolimus and betamethasone were highly effective in the treatment of seborrhoeic dermatitis. Betamethasone reduced all three parameters, erythema, scaling and pruritus, faster than pimecrolimus, but the differences in reduction were not statistically significant. Relapses were observed more frequently and were more severe with betamethasone than with pimecrolimus. Moreover, pruritus was not observed after discontinuation of treatment from day 15 and beyond in the pimecrolimus group, whereas it was reported in most patients of the betamethasone group. This difference was statistically significant. CONCLUSIONS: It appears that pimecrolimus, a nonsteroidal topical treatment, may be an excellent alternative therapeutic modality for treating seborrhoeic dermatitis.     

Chloroxylenol and zinc oxide containing cream (Nels cream) vs. 5% benzoyl peroxide cream in the treatment of acne vulgaris. A double-blind, randomized, controlled trial

Forty-one subjects completed a double-blind controlled randomized study comparing the following: (i) Nels cream (containing chloroxylenol and zinc oxide); (ii) 5% benzoyl peroxide cream; and (iii) the vehicle of the Nels cream. Patients applied the medications twice daily for 8 weeks. At the end of the test period there was no significant difference in the reduction of inflammatory and noninflammatory lesion counts achieved by Nels cream and benzoyl peroxide. Both creams proved superior to the vehicle. Efficacy grading by subjects and investigators showed no significant difference between Nels cream and benzoyl peroxide. However, side-effects such as peeling and dryness caused by the treatment were significantly less in the Nels cream group.     

The 24‐hr, 28‐day,and 7‐day post‐moisturizing efficacy of ceramides 1, 3, 6‐II containing moisturizing cream compared with hydrophilic cream on skin dryness and barrier disruption in senile xerosis treatment

Direct replacement of decreased ceramides in the stratum corneum can be efficacious for skin hydration, skin barrier function, and skin pH. Our study aimed to evaluate the 24‐hr, 28‐day, and 7‐day post‐moisturizing efficacy of ceramide‐containing moisturizer in senile xerosis treatment. A split site, double‐blinded, randomized, controlled study was conducted in 24 senile subjects (91.7% females, mean age 54.83 ± 5.45 years) with mild to moderate xerosis, who were randomized to receive ceramide‐containing moisturizer or hydrophilic cream, daily applied on each side of the shin. A single application of ceramide‐containing moisturizer increased skin hydration, while improving transepidermal water loss (TEWL) and skin pH for up to 24 hr, with statistically significant difference. After 28 days of twice‐daily application, more significant improvement on skin hydration, barrier function, and skin pH was observed in those with ceramide‐containing moisturizer at all‐time points. At day 28, there was a statistically significant decrease of hemoglobin index, wrinkle, and texture on the ceramide treated side. The 7‐day post‐moisturizing efficacy on the ceramide treated side was superior for skin hydration, TEWL, skin pH, and wrinkle. Thus, the ceramide‐containing moisturizer can be a novel promising treatment for senile xerosis.     

A comparison of metronidazole 1% cream and pimecrolimus 1% cream in the treatment of patients with papulopustular rosacea: a randomized open‐label clinical trial

Background. There are various treatment options available for rosacea, depending on the subtype, but treatment is still generally unsatisfactory. Some reports have indicated beneficial effects of topical pimecrolimus. Aim. To compare the efficacy and safety of pimecrolimus 1% cream and metronidazole 1% cream in the treatment of patients with papulopustular rosacea (PR). Methods. A group of 49 patients with PR was investigated in this single‐centre, randomized, open‐label study. Patients were randomly assigned treatment with either pimecrolimus 1% cream or metronidazole 1% cream for 12 weeks. Response was evaluated by the inflammatory lesion count, the severity of facial erythema and telangiectasia, Physician’s Global Assessment (PGA), and safety and tolerability at baseline and at weeks 3, 6, 9 and 12. Results. In total, 48 patients completed the study. Both treatments were very effective in the treatment of PR. There were no significant differences between the treatments in inflammatory lesion counts, overall erythema severity scores and PGA evaluated from baseline to week 12 (P > 0.05). Neither treatment produced any clinically relevant improvement in telangiectasia. Conclusion. Pimecrolimus cream is no more efficacious than metronidazole cream in the treatment of PR.     

A double-blind clinical trial with a lotion containing 5% benzoyl peroxide and 2% miconazole in patients with acne vulgaris

The therapeutic efficacy of a lotion containing 5% benzoyl peroxide and 2% miconazole was compared with 5% benzoyl peroxide alone, in a double-blind, randomized, parallel study. Thirty patients with comedonal or inflammatory acne vulgaris were enrolled. The medications were applied once daily during the first week, and then twice daily for the rest of the trial (45 days). In patients with comedonal acne there was no difference in the effect of the two therapies. In patients with inflammatory acne the percentage reduction of the number of lesions on Day 30 was significantly higher in the benzoyl peroxide plus miconazole group (66%) compared to benzoyl peroxide alone (37%). At Day 45 there was a trend favouring the combined therapy but the difference was not significant. There were no significant differences in the adverse reactions reported by the two groups of patients (erythema, itching or moderate exfoliation).     

Adapalene gel 0.1% vs ketoconazole cream 2% and their combination in treatment of pityriasis versicolor: A randomized clinical study

Pityriasis versicolor (PV) is a chronic superficial fungal infection. Management using azole drugs leads to drug resistance. The present study aimed to compare the clinical outcome of 0.1% adapalene gel vs 2% ketoconazole cream and their combination in PV. This randomized double‐blinded study was conducted on 90 PV patients divided into three equal groups. GI was treated with topical ketoconazole 2% cream twice daily and placebo, GII was treated with topical 0.1% adapalene gel twice daily and placebo and GIII was treated with topical combination of 0.1% adapalene gel (at night) and ketoconazole 2% cream (in the morning). All patients received medications for 4 weeks. Evaluation was done at 2 and 4 weeks and included clinical assessment, laboratory assessment, and patient satisfaction. We found that after 4 weeks of treatment, all groups showed significant improvement. There was better response in GIII in terms of lower rate of positive potassium hydroxide staining, higher rate of significantly improved cases and higher rate of well‐satisfied patients. However, the difference fell short of statistical significance. We concluded that a combination of adapalene gel and ketoconazole cream is very effective in treatment of PV with no or mild side effects.     

异维A酸软膏治疗寻常痤疮的多中心随机对照研究

目的评价异维A酸软膏治疗寻常痤疮的疗效和安全性。方法人组寻常痤疮患者240例,分别应用0．05%异维A酸软膏或0．05%维A酸乳膏,每晚1次,疗程8周。通过炎性皮损和非炎性皮损计数观察疗效,评价红斑、脱屑、烧灼感等局部不良反应。结果治疗8周,试验组皮损总数目从45．52±19．80减少至16．24±16．10,对照组皮损总数目从44．00±19．13减少至12．24±11．34,试验组有效率为69．75%,对照组有效率为80．51%,差异无统计学意义(P＞0．05),两组局部不良反应发生率差异无统计学意义(P＞0．05)。结论异维A酸软膏治疗寻常痤疮安全有效,其临床疗效及皮肤耐受性同0．05%维A酸乳膏相似。     

A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men

BACKGROUND: Topical minoxidil solution 2% stimulates new hair growth and helps stop the loss of hair in individuals with androgenetic alopecia (AGA). Results can be variable, and historical experience suggests that higher concentrations of topical minoxidil may enhance efficacy. OBJECTIVE: The purpose of this 48-week, double-blind, placebo-controlled, randomized, multicenter trial was to compare 5% topical minoxidil with 2% topical minoxidil and placebo in the treatment of men with AGA. METHODS: A total of 393 men (18-49 years old) with AGA applied 5% topical minoxidil solution (n = 157), 2% topical minoxidil solution (n = 158), or placebo (vehicle for 5% solution; n = 78) twice daily. Efficacy was evaluated by scalp target area hair counts and patient and investigator assessments of change in scalp coverage and benefit of treatment. RESULTS: After 48 weeks of therapy, 5% topical minoxidil was significantly superior to 2% topical minoxidil and placebo in terms of change from baseline in nonvellus hair count, patient rating of scalp coverage and treatment benefit, and investigator rating of scalp coverage. Hair count data indicate that response to treatment occurred earlier with 5% compared with 2% topical minoxidil. Additionally, data from a patient questionnaire on quality of life, global benefit, hair growth, and hair styling demonstrated that 5% topical minoxidil helped improve patients' psychosocial perceptions of hair loss. An increased occurrence of pruritus and local irritation was observed with 5% topical minoxidil compared with 2% topical minoxidil. CONCLUSION: In men with AGA, 5% topical minoxidil was clearly superior to 2% topical minoxidil and placebo in increasing hair regrowth, and the magnitude of its effect was marked (45% more hair regrowth than 2% topical minoxidil at week 48). Men who used 5% topical minoxidil also had an earlier response to treatment than those who used 2% topical minoxidil. Psychosocial perceptions of hair loss in men with AGA were also improved. Topical minoxidil (5% and 2%) was well tolerated by the men in this trial without evidence of systemic effects.