Patient-reported outcomes from a multicenter, randomized, vehicle-controlled clinical study of MAS063DP (Atopiclair) in the management of mild-to-moderate atopic dermatitis in adults.

BACKGROUND: MAS063DP (Atopiclair) is a topical cream approved for symptomatic relief in the treatment of atopic and contact dermatitis. METHODS: This was a multicenter, randomized, double-blind, vehicle-controlled study in adults with mild-moderate atopic dermatitis. Patients were given MAS063DP or vehicle (2:1) three times per day to areas affected by atopic dermatitis for up to 50 days. A patient global assessment change from baseline was determined at days 8, 22, 36, and 50. Patient total body pruritus (visual analog scale) and patient opinion on treatment acceptability were also assessed. RESULTS: A total of 218 patients (active: n = 145, vehicle: n = 73) were enrolled. At Day 22, 77% of patients on MAS063DP had a patient global assessment of good improvement or better versus 21% on vehicle (p<0.0001, chi-squared test). Similarly, more patients had improvement in itch over their total body on MAS063DP than on vehicle (p<0.0001). CONCLUSION: MAS063DP treatment results in patient-perceived improvements in mild-moderate atopic dermatitis.

Ketoconazole gel 2% in the treatment of moderate to severe seborrheic dermatitis.

Seborrheic dermatitis traditionally has been treated with topical steroids. In current practice, however, antifungal agents such as ketoconazole often are used because Malassezia yeasts are thought to play a role in the disease pathogenesis. Ketoconazole gel 2% has been developed for the once-daily treatment of seborrheic dermatitis. This gel is almost invisible after application, unlike ketoconazole cream, and may offer advantages in patient acceptance and adherence to treatment. Three randomized, double-blinded, vehicle-controlled, multicenter, parallel-group phase 3 studies evaluated the efficacy and tolerability of ketoconazole gel 2% compared with a vehicle gel in more than 900 subjects with moderate to severe seborrheic dermatitis who applied treatment for 14 days and were followed for an additional 14 days. Two of these studies also compared a combination gel containing ketoconazole 2% and desonide 0.05%, each active gel individually, and a vehicle control. Subjects were considered effectively treated if the erythema and scaling as well as investigator global assessment (IGA) scores decreased to 0 (or 1 if the baseline score was > or =3) by day 28. Pooled data from these studies showed that the proportion of effectively treated subjects was significantly greater in the ketoconazole gel 2% treatment group compared with the vehicle group (P < .001). The comparison of the combination gel to its individual components revealed that the efficacy of ketoconazole alone was comparable to the combination gel as well as desonide gel alone for up to 2 weeks after the end of treatment. These data suggest that once-daily ketoconazole gel 2% is an effective treatment for seborrheic dermatitis and a viable alternative to the ketoconazole cream 2% formulation.

Evaluation of the efficacy and safety of clobetasol propionate spray in the treatment of plaque-type psoriasis.

Treatment of the inflammatory component of plaque psoriasis is an important part of psoriasis management. A new and unique spray formulation of clobetasol propionate 0.05% may provide advantages over the currently available formulations through easy application to hard-to-reach areas and the ability to deliver a fixed dose of corticosteroid per spray. The purpose of this study was to evaluate the efficacy and safety of clobetasol propionate spray 0.05% in the treatment of moderate to severe plaque-type psoriasis. This study was conducted as a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group, comparative study in subjects with plaque psoriasis. Subjects were randomized to receive either clobetasol propionate spray 0.05% (n=60) or vehicle spray (n=60) twice daily for 4 weeks, followed by a 4-week treatment-free follow-up period. Efficacy evaluations at all visits included assessment of scaling, erythema, plaque elevation, pruritus, and overall disease severity. Success rates for each of the signs and symptoms evaluated, as well as for the overall disease severity assessment, were significantly in favor of clobetasol propionate (P<.001). The additional 2 weeks of treatment from weeks 2 to 4 increased the number of cleared subjects from 2% to 25%; treatment success was still in favor of clobetasol propionate (P<.001) at week 8 (4 weeks post-treatment). No treatment-related serious adverse events occurred during the course of the study. Mild application site burning/stinging was the most common treatment-related adverse event, with similar frequency and severity for both active and vehicle groups. There were no reports of skin atrophy, telangiectasia, folliculitis, or hypothalamus-pituitary-adrenal axis suppression. Overall, clobetasol propionate spray 0.05% administered twice daily for 4 weeks was effective and safe in reducing scaling, erythema, plaque elevation, and overall disease severity and demonstrates durable clinical response up to 4 weeks after treatment end.

Efficacy and tolerability of combined topical treatment of acne vulgaris with adapalene and clindamycin: a multicenter, randomized, investigator-blinded study.

This multicenter, randomized, investigator-blinded study investigated the efficacy and tolerability of adapalene gel 0.1% plus clindamycin phosphate lotion 1%, compared with clindamycin plus vehicle for the treatment of mild to moderate acne vulgaris. A total of 249 patients applied clindamycin lotion twice daily and adapalene (125 patients) or vehicle gel (124 patients) once daily for 12 weeks. A significantly greater reduction of total (P <.001), inflammatory (P =.004) and noninflammatory lesions (P <.001) was seen in the clindamycin plus adapalene group than in the clindamycin plus vehicle group. These significant treatment effects were observed as early as week 4 for both noninflammatory and total lesion counts. Both treatment regimens were well tolerated. Although the worst scores for scaling (P <.05), dryness (P <.01), and stinging/burning (P <.05) were higher in the clindamycin plus adapalene group than in the clindamycin plus vehicle group in patients with moderate or severe irritation; in most cases these symptoms were of mild intensity.