Efficacy of a new antidandruff thermophobic foam: a randomized, controlled, investigator-blinded trial vs. ketoconazole 2% scalp fluid

Background Ketoconazole (K), zinc pyrithione (ZP), and salicylic acid (SA) are compounds active in the treatment of dandruff. A thermophobic foam formulation containing K 1%, ZP 0.5%, and SA 2% is now available. Study aim To compare the efficacy of thermo phobic foam with K 2% scalp fluid in the treatment of moderate to severe dandruff. Patients and methods In a randomized, prospective, parallel‐group, investigator‐blinded, 4‐week treatment trial, a total of 54 patients (mean age 43 ± 8 years) were enrolled. Foam (F group) (n = 37) or K 2% scalp fluid (SF group) (n = 17) was applied daily for 7 days and twice weekly for 3 weeks thereafter. Clinical assessment of the total dandruff severity score (TDSS) was performed at baseline, after 2 and 4 weeks. The TDSS was calculated using a four‐grade quantitative score (0 = no dandruff; 3 = severe dandruff) dividing the scalp area into four zones and adding the single score for each area. Results At baseline, TDSS was 7.1 ± 2 and 5.1 ± 1 in the F and SF groups, respectively. At the end of treatment period, beneficial effects were observed in both groups. The TDSS was reduced to 2.5 ± 1 in the F group and to 3.7 ± 1.2 in the SF group (mean difference in favor of F group: ?1.2; 95% CI: –0.57 to ?1.8) (P = 0.0003). A complete or nearly complete resolution of dandruff was observed in 24 out of 37 (64%: 95%CI: 48–77%) in the F group and in 7 out of 17 (41%: 95% CI: 21–64%) in the SF group (P = 0.06 between groups). Conclusions This new antidandruff thermophobic foam has shown to be more effective than ketoconazole 2% scalp fluid in the treatment of severe dandruff.     

Ciclopirox gel for seborrheic dermatitis of the scalp

Background Seborrheic dermatitis is a common inflammatory skin disorder that usually occurs in patients with pre‐existing seborrhea. The etiology of seborrheic dermatitis is uncertain. Typically, sites dense with sebaceous glands support growth of the lipophilic yeast Malassezia furfur. Ciclopirox (Loprox®) gel is a hydroxypyridone, broad‐spectrum antifungal agent proven effective against the yeast M. furfur. Objective A multicenter, randomized, double‐blind, vehicle controlled study of 178 subjects evaluated the efficacy of ciclopirox gel in treating seborrheic dermatitis of the scalp. Methods One hundred and seventy‐eight subjects were randomized to apply either ciclopirox gel 0.77% twice daily, or vehicle twice daily for 28 days. Subjects’ signs and symptoms of severity (erythema, scaling, pruritus and burning) were rated on a scale of 0–3 (none to severe); for inclusion, a minimum score of 4, for the sum of the individual ratings was required. Efficacy evaluations were performed at baseline, days 4, 8, 15, 22, 29, and at end‐point (final visit, up to day 33). The primary efficacy variable was clinical response assessed by a global improvement, based on a scale of 0–5 (100% clearance to flare of treatment area). Changes in signs/symptoms severity scores within the target lesion were also evaluated. Results Global evaluation scores demonstrated that significantly more ciclopirox‐treated subjects achieved over 75% improvement compared with vehicle at days 22, 29, and endpoint (P < 0.01). Change‐from‐baseline mean score for total signs and symptoms was significantly greater in ciclopirox subjects compared with vehicle subjects at the same time points as above (P < 0.001), as well as day 15 (P < 0.01). Twenty‐nine percent of subjects rated ciclopirox as having excellent cosmetic acceptability. There were only mild adverse events, with the most common being burning sensation in 13% of ciclopirox subjects and 9% of vehicle subjects. Conclusion Ciclopirox gel is effective and safe in the treatment of seborrheic dermatitis of the scalp.     

Randomized study comparing the efficacy and tolerance of a lipophillic hydroxy acid derivative of salicylic acid and 5% benzoyl peroxide in the treatment of facial acne vulgaris

Background  New topical treatments for acne vulgaris are needed for patients who have tolerance problems with current treatments.
Aims  To compare the efficacy and tolerance of a lipophillic derivative of salicylic acid (lipo hydroxy acid or LHA) containing formulation and 5% benzoyl peroxide in subjects with acne vulgaris.
Methods  Eighty subjects with mild to moderate facial acne were randomized to receive either the LHA formulation twice a day or benzoyl peroxide once a day for 12 weeks. Efficacy and tolerance were evaluated at days 0, 28, 56 and 87.
Results  LHA formulation and benzoyl peroxide decreased the number of inflammatory lesions from baseline to week 12 by 44% and 47% and noninflammatory lesions by 19% and 23%, respectively. There was no statistically significant difference between the two treatments ( P =  0.748; P  = 0.445).
Conclusion  These results suggest that the LHA formulation could be a treatment option to consider in mild to moderate acne vulgaris patients that are intolerant to benzoyl peroxide.     

Twice-daily versus Once-daily Applications of Pimecrolimus Cream 1% for the Prevention of Disease Relapse in Pediatric Patients with Atopic Dermatitis

Abstract:  The aim of this study is to compare twice-daily and once-daily applications of pimecrolimus cream 1% for prevention of atopic dermatitis relapses in pediatric patients. This multicenter trial enrolled 300 outpatients aged 2 to 17 years, with mild-to-severe atopic dermatitis. The patients were initially treated with twice-daily topical pimecrolimus until complete clearance or for up to 6 weeks (open-label period). Those who achieved a decrease of at least 1 point in the Investigator's Global Assessment score were then randomized to double-blind treatment with pimecrolimus cream 1% either twice daily or once daily for up to 16 weeks. Study medication was discontinued during periods of disease remission (Investigator's Global Assessment = 0). The primary efficacy end point of the double-blind phase was disease relapse (worsening requiring topical corticosteroids or additional/alternative therapy and confirmed by Investigator's Global Assessment score ≥ 3 and pruritus score ≥ 2). Of the 300 patients enrolled in the study, 268 were randomized to treatment with pimecrolimus cream 1% either twice daily or once daily ( n  = 134 in each group). The relapse rate was lower in the twice-daily dose group (9.9%) than that in the once-daily dose group (14.7%), but analysis of the time to disease relapse, using a Cox proportional model to adjust for confounding variables, did not show a statistically significant difference between treatment arms (hazard ratio: 0.64; 95% CI: 0.31–1.30). Treatment of active atopic dermatitis lesions with pimecrolimus cream 1% twice daily, followed by the once-daily dosing regimen, was sufficient to prevent subsequent atopic dermatitis relapses over 16 weeks in pediatric patients.     

Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double-blind,randomized, vehicle-controlled study

Introduction

Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis-prone scalp.

Objective

To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis.

Materials and methods

A single-center, randomized, double-blind, vehicle-controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis–specific quality-of-life issues using SCALPDEX and product acceptability.

Results

The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject-reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL.

Conclusion

The active shampoo significantly improved clinical signs, symptoms, and QoL of mild-to-moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects.     

Long-term management of facial atopic eczema with pimecrolimus cream 1% in paediatric patients with mild to moderate disease

Background The aim of this post hoc analysis was to evaluate whether treatment of patients with atopic dermatitis (AD) with pimecrolimus cream 1% can decrease the development of flares necessitating the use of a topical corticosteroid on the face and thus reduce the need for use of topical corticosteroids in this sensitive skin area. Patients and methods In a controlled, double‐blind, multicentre study, 140 patients, aged 2 to 17 years, with facial involvement and mild to moderate disease after treatment of the initial flare with prednicarbate 0.25% cream were randomized to an intermittent treatment with pimecrolimus cream 1% twice daily or vehicle for 24 weeks. If a flare occurred, defined as an exacerbation (unacceptable severity of itching/scratching or onset of oozing) not controlled by study medication, patients were treated with prednicarbate 0.25% cream instead. Results Patients in the vehicle group needed prednicarbate treatment on the face on 20.7% of the days vs. 11.7% of the study days in the pimecrolimus group (P = 0.0024). Fifty per cent of patients in the pimecrolimus group had no flare on the face during the treatment period compared with 37.5% of patients in the vehicle group (P = 0.012). The median time to first flare in pimecrolimus‐treated patients was twice as long as in patients receiving vehicle (138 vs. 68 days, P = 0.01). Three adverse events (one case of skin burning) suspected to be related to use of the study medication were reported for three patients (3.9%) in the pimecrolimus group. Conclusion Long‐term intermittent treatment of facial AD in children and adolescents with pimecrolimus cream 1% does significantly reduce the need for topical corticosteroids.     

Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial

Background Seborrheic dermatitis is a common inflammatory skin disorder. Yeasts of the genus Malassezia have been implicated in the etiology of seborrheic dermatitis, although this connection remains controversial. Ciclopirox is a synthetic, hydroxypyridone‐derived, broad‐spectrum antifungal agent with anti‐inflammatory properties. Methods A total of 499 US patients with seborrheic dermatitis of the scalp were randomized to apply either ciclopirox shampoo 1% or vehicle twice weekly for 4 weeks. The main efficacy parameters were based on 6‐point ordinal scales describing the disease's signs and symptoms (scaling, erythema and itching) and a 6‐point scale providing a global evaluation of the status of seborrheic dermatitis. Results Ciclopirox was significantly better than vehicle in effectively treating seborrheic dermatitis. ‘Effective treatment’ (score of 0 or 1 for disease status, scaling and erythema) was achieved in 26.0% of ciclopirox‐treated patients compared with 12.9% of vehicle‐treated patients (P = 0.0001; OR: 2.383, 95% CI: 1.494–3.799). The majority of subjects experienced adverse events that were mild in intensity, with skin and appendage reactions the most commonly reported, at similar frequency in both groups. Conclusions Ciclopirox shampoo 1% is effective and safe in the treatment of seborrheic dermatitis of the scalp.     

Pimecrolimus 1% cream versus betamethasone 17-valerate 0.1% cream in the treatment of facial discoid lupus erythematosus: a double-blind, randomized pilot study

Background.  Discoid lupus erythematosus (DLE) is commonly treated with topical agents, the most important of which are glucocorticosteroids. However, prolonged use of these agents, especially on sensitive areas such as the face, may result in side-effects (e.g. atrophy and telangiectases) by altering collagen synthesis. Therefore, alternative treatments are needed for these patients.
Aim.  To investigate and compare the efficacy of topical pimecrolimus 1% cream and topical betamethasone 17-valerate 0.1% cream on facial lesions of DLE.
Methods.  This was a randomized double-blind pilot study, performed in outpatient clinics of two major referral hospitals. Ten patients aged 20–53 years with moderate to severe DLE of the face were randomized into two groups for 8 weeks of treatment and 8 weeks of follow-up after treatment. In this double-blind study, one group applied pimecrolimus 1% cream twice daily and the other group applied betamethasone valerate 0.1% cream twice daily to facial lesions. Efficacy end-points included a combined score based on evaluation of erythema, infiltration and presence of scale.
Results.  Efficacy end-points showed significant improvement in both groups. A decrease of 86% and 73% in clinical severity scores was obtained for pimecrolimus and betamethasone, respectively ( P  = 0.043). There was no significant difference between the two groups in terms of efficacy ( P  = 0.1). No adverse effect was found at the end of the 8-week trial in any of our patients.
Conclusions.  The efficacy of pimecrolimus 1% cream is comparable with that of betamethasone valerate 0.1% cream in treating facial DLE.     

Efficacy of 5% Minoxidil versus Combined 5% Minoxidil and 0.01% Tretinoin for Male Pattern Hair Loss

Background: 5% topical minoxidil solution has been widely used to stimulate new hair growth and help stop hair loss in men with androgenetic alopecia (AGA). However, it is not convenient for patients to continue applying the solution twice daily on a regular basis. Tretinoin is known to increase the percutaneous absorption of minoxidil and, therefore, to enhance the response of AGA to minoxidil. For this reason, it was assumed that tretinoin would be helpful in alleviating the inconvenience associated with the recommended twice-daily application of minoxidil. Objective: To compare the efficacy and safety of therapy using a combined solution of 5% minoxidil and 0.01% tretinoin once daily with those of the conventional 5% topical minoxidil therapy applied twice daily in the treatment of AGA. Methods: A total of 31 male patients (aged 28–45 years, mean 39.7 ± 4.5) with AGA (Hamilton-Norwood classification type III–V) were randomly assigned into two groups, one in which 5% minoxidil was applied to the scalp twice daily and the other in which the combined agent was applied once daily at night together with a vehicle placebo in the morning. The efficacy parameters were: (i) changes in total hair count, non-vellus hair count, anagen hair ratio, linear hair growth rate, and mean hair diameter assessed by macrophotographic image analysis; and (ii) the patient’s and investigator’s subjective assessments. Results: After therapy, increases in the macrophotographic variables of total hair count and non-vellus hair count were shown in both treatment groups. There were no statistically significant differences between the two treatment groups with respect to changes in macrophotographic variables or scores on subjective global assessments by patients and the investigator. The incidence of adverse effects such as pruritus or local irritation was similar in the 5% minoxidil group (4 of 14 subjects) and the combined agent group (5 of 15 subjects). Conclusion: The efficacy and safety of combined 5% minoxidil and 0.01% tretinoin once-daily therapy appear to be equivalent to those of conventional 5% minoxidil twice-daily therapy for the treatment of AGA.     

Randomized study comparing the efficacy and tolerance of a lipohydroxy acid shampoo to a ciclopiroxolamine shampoo in the treatment of scalp seborrheic dermatitis

Background The success of a dandruff treatment depends not only on the ability of a shampoo to control dandruff, but also on patient compliance, which is closely linked to the cosmetic attributes of the product. Aim The aim of this study was to compare efficacy, tolerance, and cosmetic properties of a LHA Shampoo [containing 0.1% lipohydroxy acid (LHA) and 1.3% salicylic acid] to a CPO shampoo [containing 1.5% ciclopiroxolamine (CPO), 3% salicylic acid, and 0.5% menthol] in subjects with seborrheic dermatitis (SD) of the scalp. Methods One hundred subjects with mild to moderate scalp SD were randomized to receive either the LHA shampoo or the CPO shampoo every 2 days for 4 weeks. Efficacy and tolerance were evaluated at days 0, 14, and 28. Results The LHA and the CPO shampoo both decreased symptoms of scale, erythema, itching, cutaneous discomfort, and dryness from baseline to day 28. A higher percentage of patients showed improvement in the group treated with the LHA formulation than in the group treated with the CPO formulation, but the difference did not reach statistical significance. At day 28, the tolerance and the global efficacy of the LHA shampoo were significantly better (P = 0.03 and P = 0.01, respectively) than those of the CPO shampoo. Furthermore, the cosmetic acceptability was better or significantly better for all the endpoints evaluated for the LHA shampoo (P = 0.02 for cleaning, P = 0.04 for lathering). Conclusion In conclusion, these results demonstrated that the lipohydroxy acid shampoo evaluated in this study is a more convenient, efficient, safe, and well‐tolerated cosmetic treatment for mild‐to‐moderate seborrheic dermatitis of the scalp than a ciclopiroxolamine shampoo.     

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.     

Mometasone furoate 0.1% and salicylic acid 5% vs. mometasone furoate 0.1% as sequential local therapy in psoriasis vulgaris

Background and objective  Treatment in psoriasis vulgaris continues to unmet needs in terms of efficacy, quality of life and costs. Patients with moderate forms of psoriasis are using topical corticosteroids as first-line therapy and patients with severe forms also use this therapy. Optimization of this treatment is made by the use of combination drugs or by the sequential or rotational therapies. A multicentric clinical study was performed to measure the efficiency of mometasone furoate 0.1% and salicylic acid 5% and mometasone furoate 0.1% as sequential local therapy in psoriasis.
Methods  This was a randomized, multicentre trial with two patient groups receiving active treatment. The study group ( N  = 184) received mometasone furoate 0.1% and salicylic acid 5% for the first 7 days of treatment, and in the following 14 days, the patients used mometasone furoate 0.1%. The second group ( N  = 176) was treated with mometasone furoate 0.1% for 21 consecutive days. Psoriasis Area Severity Index (PASI) score and Dermatology Life Quality Index (DLQI) were calculated.
Results  After the first week of treatment in the study group, the reduction of PASI score was 44%, statistically significant greater than the reduction of PASI score in the second group (37%). Quality of life estimated by DLQI indicated significant lower values in the first (study) group.
Conclusion  The sequential treatment mometasone furoate 0.1% and salicylic acid 5% followed by mometasone furoate 0.1% proves to be efficient, safe and an excellent option for the following sequence: in-patient and out-patient.

Conflict of Interest

None declared.     

Topical use of caffeine with hydrocortisone in the treatment of atopic dermatitis.

In a double-blind study, topically applied caffeine 30%-hydrocortisone 0.5% in hydrophilic ointment was compared to betamethasone valerate 0.1% cream and to hydrocortisone 0.5% in hydrophilic ointment. Eighty-three patients were evaluated over a three-week period for pruritus, erythema, scaling, lichenification, excoriation, oozing, and global impression. The betamethasone and caffeine-hydrocortisone groups performed significantly better than the hydrocortisone group on three of the seven scales: lichenification, excoriation, and global impression. Also, the betamethasone group differed significantly from the hydrocortisone group on six of the seven scales, but did not differ significantly from the caffeine-hydrocortisone group on any scale. It is suggested that caffeine is effective because it elevates local levels of cyclic adenosine-3',5'-monophosphate by inhibiting phosphodiesterase.     

A comparison of once-daily application of mometasone furoate 0.1% cream compared with twice-daily hydrocortisone valerate 0.2% cream in pediatric atopic dermatitis patients who failed to respond to hydrocortisone

Two hundred and nineteen patients completed this multicenter, randomized, evaluator-blind, parallel-group study evaluating the efficacy and safety of once-daily application of mometasone furoate 0.1% cream compared with twice-daily hydrocortisone valerate 0.2% cream in children with moderate to severe atopic dermatitis. Enrolled patients were between 2 and 12 years of age and had failed to respond to at least 7 consecutive days of treatment with a topical hydrocortisone preparation, with the last application of hydrocortisone occurring within a week before enrolling in the current study. Patients were randomized to treatment from 10 centers in the USA with either mometasone furoate 0.1% cream (n = 109) or hydrocortisone valerate 0.2% cream (n = 110) for up to 3 weeks. At enrollment, a target area of dermatitis (not the face or forehead) of at least 20 cm² was selected by the investigator for specific evaluation of the effects of treatment on disease signs and symptoms. Additionally, patients had to present with at least 15% total body surface involvement, excluding the face and forehead, with the current exacerbation of atopic dermatitis. The severity of erythema, induration/lichenification, scaling/crusting, exudation, excoriation, and pruritus was graded on the following scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe. A total sign/symptom severity score (sum of six individual sign/symptom severity scores) of ≥ 8 was required in the target area (maximum = 18), with a severity score of ≥ 2 required for erythema and for one other sign. Patients were examined on return visits on days 4, 8, 15, and 22 of treatment and the severity of the signs and symptoms present in the target area was rated by the investigator at each visit. Areas outside the target area were also treated with the study medications and evaluated by the investigator in the global response to treatment. The criteria for global clinical response compared to baseline were as follows: cleared (100% improvement); excellent (75–99% improvement); good (50–74% improvement); fair (25–49% improvement); poor (< 25% improvement); exacerbation (a flare-up at a treatment site). No other therapies for atopic dermatitis were permitted.     

Efficacy of dioic acid compared with hydroquinone in the treatment of melasma

Background  Melasma is a common disorder of pigmentation characterized by relatively symmetric, brown or gray–brown patches on sun-exposed facial areas. Hydroquinone, the most effective agent in melasma, is known to irritate the skin, and so new alternatives in the treatment of melasma are required. We sought to assess the clinical response of a new depigmenting agent in melasma.
Methods  Ninety-six Mexican female patients with melasma were enrolled in this open, comparative, 12-week study. The patients received 1% dioic acid cream (twice daily) or 2% hydroquinone cream (twice daily).
Results  There was a significant difference in the Melasma Area Severity Index (MASI) scores from baseline to the end of the study using treatment with dioic acid (baseline, 14.52 3.4; after 12 weeks of treatment, 6.05 ± 1.2; P  = 0.001) and hydroquinone (baseline, 15.22 ± 2.4; after 12 weeks of treatment, 6.34 ± 1.3; P  = 0.001); however, there were no significant differences between treatments (baseline, P  = 0.311; after 12 weeks of treatment, P  = 0.287). The side-effects were similar with both medications; however, pruritus was more common in patients using hydroquinone.
Conclusions  Dioic acid is an effective and highly tolerated skin product, although further controlled, blind, multicenter studies are required to support these results.     

Randomized clinical trial comparing 5% and 1% topical minoxidil for the treatment of androgenetic alopecia in Japanese men

Minoxidil is efficacious in inducing hair growth in patients with androgenetic alopecia by inducing hair follicles to undergo transition from the early to late anagen phase. Although the efficacy of 1% topical minoxidil has been confirmed in Japan, no controlled study of 5% topical minoxidil has been conducted using male Japanese subjects. The objective of this trial was to verify the superiority in clinical efficacy of 5% topical minoxidil to 1% topical minoxidil in a double-blind controlled study with male, Japanese androgenetic alopecia patients as the subjects. The trial included 300 Japanese male patients aged 20 years or older with androgenetic alopecia who were administered either 5% topical minoxidil ( n  = 150) or 1% topical minoxidil ( n  = 150) for 24 weeks. The mean change from the baseline in non-vellus hair/cm², the primary efficacy variable, was 26.4 ( n  = 142) in the 5% topical minoxidil group and 21.2 ( n  = 144) in the 1% topical minoxidil group at 16 weeks, the main time point for the evaluation. The difference between the groups was significant ( P  = 0.020). The incidence of adverse events was 8.7% (13/150) in the 5% group and 5.3% (8/150) in the 1% group, with no significant difference between the groups (χ²-test: P  = 0.258). Our findings confirmed the superiority of 5% topical minoxidil to 1% topical minoxidil in treating Japanese men with androgenetic alopecia.     

Randomized controlled trial comparing the effectiveness of 308-nm excimer laser alone or in combination with topical hydrocortisone 17-butyrate cream in the treatment of vitiligo of the face and neck

Background Vitiligo is a pigmentary disorder which may have disfiguring consequences. Its treatment remains a challenge. Objectives We designed a parallel‐group randomized controlled trial to compare the effectiveness of 308‐nm excimer laser alone or in combination with topical hydrocortisone 17‐butyrate cream in patients with vitiligo unresponsive to previous treatment with topical steroids or narrow‐band ultraviolet (UV) B phototherapy. Methods Consecutive patients aged 18–75 years with nonsegmental vitiligo localized on the face and/or neck lacking response to previous conventional treatment were eligible. In total, 84 patients (44 women and 40 men, mean age 44 years) were randomized to 308‐nm excimer laser phototherapy twice weekly alone or in combination with topical hydrocortisone 17‐butyrate cream twice daily for three periods of 3 weeks followed by a 1‐week steroid‐free interval. The primary outcome was a reduction of at least 75% of the overall lesional areas as judged by automatic image analysis on reflected UV photographs, conducted blind to treatment assignment, at 12 weeks compared with baseline. Secondary outcomes were clearance, and improvements on Physician’s Global Assessment (PGA) and Skindex‐29 scores. Results A total of 76 (90%) patients completed the study. In an intention‐to‐treat analysis, seven [16·6%; 95% confidence interval (CI) 5·3–27·8%] patients in the excimer monotherapy arm and 18 (42·8%; 95% CI 27·8–57·8%) in the combination arm showed ≥ 75% reduction of vitiligo lesions at 12 weeks (χ² test 6·89, P = 0·0087). Clearance was observed in two (4·7%; 95% CI 1·6–11·2%) and nine (21·4%; 95% CI 9·0–33·8%) patients, respectively (Fisher’s exact test P = 0·04). A significant difference also emerged for PGA scores, while no difference was documented for Skindex‐29. Conclusions Recalcitrant vitiligo of the face and neck may benefit from the combination of excimer laser phototherapy with topical hydrocortisone 17‐butyrate cream.     

Randomized trial of electrodynamic microneedle combined with 5% minoxidil topical solution for the treatment of Chinese male Androgenetic alopecia

ABSTRACT

Background: In treating androgenetic alopecia, 5% minoxidil is a commonly used topical drug. By using electrodynamic microneedle at the same time may increase absorption of minoxidil and further stimulate hair growth.

Objective: A 24-week, randomized, evaluator blinded, comparative study was performed to evaluate the efficacy of treating Chinese male androgenetic alopecia using microneedle combined with 5% minoxidil topical solution. Methods: Randomized subjects received topical 5% minoxidil (group 1, n = 20), local electrodynamic microneedle treatments (group 2, n = 20), or local electrodynamic microneedle treatments plus topical 5% minoxidil (group 3, n = 20). A total of 12 microneedle treatments were performed every 2 weeks with 2ml 5% minoxidil delivery in group three during each microneedle treatment. Patient receiving topical 5% minoxidil applied 1 ml of the solution twice daily over the course of the study. A total of 60 Chinese male subjects with Norwood-Hamilton type III-VI androgenetic alopecia were treated.

Results: The mean improvement in total hair density from baseline to 24 weeks was 18.8/cm² in group 1, 23.4/cm² in group 2, and 38.3/cm² in group 3. The hair growth in the three groups was significantly different (P = 0.002), but there were no significant differences in toxicity found between the three groups.

Conclusions: Treatment with microneedle plus topical 5% minoxidil was associated with the best hair growth.     

5% 5-Fluorouracil Cream for Treatment of Verruca Vulgaris in Children

Abstract:   Warts are a common pediatric skin disease. Most treatments show only modest benefit, and some are poorly tolerated because of pain. 5-fluorouracil interferes with deoxyribonucleic acid and ribonucleic acid synthesis, and is used to treat genital warts in adults. Efficacy, safety, and tolerability of topical 5% 5-fluorouracil for treatment of common warts were examined in an open-label pilot study with pediatric patients. Thirty-nine children who have at least two hand warts applied 5% 5-fluorouracil cream (Efudex, Valeant Pharmaceuticals International) once or twice daily, under occlusion for 6 weeks. Assessment of treatment response and side effects was performed at baseline, treatment completion, and 3- and 6-month follow-ups. Hematology measures, liver function tests, and medication blood levels were reassessed at treatment completion. Eighty-eight percent of treated warts improved after 6 weeks of treatment, and 41% of subjects had complete resolution of at least one wart. Treatment response did not differ between once or twice daily applications. Tolerability and patient satisfaction were excellent. No subject had clinically significant blood levels of 5-fluorouracil. At 6 month follow-up, 87% of complete responders had no wart recurrence. Topical 5% 5-fluorouracil is a safe, effective, and well-tolerated treatment for warts in children.