Michael D. Baker

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.

Cumulative irritancy comparison of adapalene gel 0.1% versus other retinoid products when applied in combination with topical antimicrobial agents

This randomized, investigator-blinded study evaluated the level of skin tolerance to adapalene gel 0.1%, tretinoin cream 0.025%, or tretinoin microsphere gel 0.1% when applied in combination with clindamycin phosphate lotion 1%, erythromycin gel 2%, benzoyl peroxide gel 5%, or erythromycin-benzoyl peroxide gel. A total of 37 subjects underwent daily application of the topical antimicrobial and retinoid products to sites on their upper back under protective patches for approximately 16 hours each day; Friday patches were left in place over the weekend. Testing continued daily for 3 weeks or until discontinuation caused by a severe adverse reaction to any of the test products or to the patch. Adapalene gel 0.1% demonstrated statistically significantly (P <.001) less irritation after repeated application under occlusive conditions than tretinoin cream 0.025% or tretinoin microsphere gel 0.1%. Moreover, the application of adapalene gel 0.1% under these conditions, concomitantly with various antimicrobial agents, was safe and well tolerated in this subject population. In view of its low irritation potential and its efficacy, adapalene gel 0.1%, in combination with antimicrobial agents should be considered for the treatment of acne vulgaris.

Adapalene 0.1% gel is better tolerated than tretinoin 0.025% gel in acne patients

BACKGROUND Adapalene is a new naphthoic acid derivative developed for the topical treatment of acne vulgaris. OBJECTIVE We describe the results of a combined safety analysis of two multicenter trials conducted in the U.S. and Europe in which adapalene 0.1% gel was compared with tretinoin 0.025% gel in the treatment of mild to moderate acne vulgaris. METHODS A total of 591 acne patients were enrolled in these investigator-masked, randomized, controlled, parallel group studies. In the two studies, each patient was randomly assigned to receive topical adapalene 0.1% gel or tretinoin 0.025% gel once daily at bedtime, for 12 weeks. In addition to assessments of efficacy and facial skin tolerance, data on adverse events were recorded at each visit or at any other time the patient reported problems. We extracted data concerning adverse reactions (i.e., adverse events judged to be related to the study treatment) from both studies and combined the results to obtain a global comparison of safety of the two products. RESULTS A total of 15 of 296 patients (5.1%) reported 19 adverse reactions in the adapalene-treated groups, compared with 27 of 295 patients (9.1%) reporting 39 adverse reactions in the tretinoin-treated groups (p < 0.05). The number of patients discontinuing the study because of adverse events was approximately twice as low with adapalene (1.3% compared with 2.4%). Most adverse reactions for both products were related to skin irritation. No systemic adverse reactions were reported. CONCLUSION The results of these two multicenter clinical studies indicate that adapalene gel is better tolerated than tretinoin gel.

Comparison of the cumulative irritation potential of adapalene gel and cream with that of erythromycin/tretinoin solution and gel and erythromycin/isotretinoin gel

BACKGROUND Adapalene is a naphthoic acid derivative with retinoid activity that is effective in the treatment of mild to moderate acne vulgaris. OBJECTIVE This study assessed the cumulative irritation potential of adapalene gel (0.1%) and adapalene cream (0.1%) compared with that of erythromycin (4%)/tretinoin (0.025%) solution, erythromycin (4%)/tretinoin (0.025%) gel, erythromycin (2%)/isotretinoin (0.05%) gel, and white petrolatum (negative control). METHODS This was a single-center, randomized, controlled, investigator-blinded, intraindividual comparison study in healthy subjects with normal skin. The cumulative irritation assay (patch test) was used to assess the potential for irritation (including erythema) of the treatments. Each subject received all study treatments, randomly applied under occlusion (patch), to sites on either side of the midline on the mid-thoracic area of the back. All patches were applied to the same sites throughout the study, unless the degree of reaction to the treatment or adhesive necessitated removal. For 3 weeks, each test material was applied daily, Monday through Friday, for approximately 24 hours; the Friday patches were left in place over the weekend for approximately 72 hours. RESULTS All 36 subjects (26 men, 10 women; age, 18-49 years [mean, 30 years]) completed the study. In the course of the study, all subjects had > or =1 application discontinued prematurely on > or =1 site due to intolerance. There were no discontinuations with white petrolatum. All erythromycin/tretinoin gel patches were discontinued at day 10; 35 of 36 erythromycin/isotretinoin gel patches were discontinued at day 9; and 35 of 36 erythromycin/tretinoin solution patches were discontinued at day 11 or day 17. The adapalene products, although slightly more irritating (mean cumulative irritation index, 0.25-1) than white petrolatum, were significantly less irritating than the erythromycin/tretinoin and erythromycin/isotretinoin products (P < 0.01). CONCLUSIONS Adapalene gel and cream were well tolerated, with possible benefits for compliance. Their low irritation potential should be considered when prescribing a topical retinoid for the treatment of acne vulgaris.

Multicenter trial for long-term safety and efficacy comparison of 0.05% desonide and 1% hydrocortisone ointments in the treatment of atopic dermatitis in pediatric patients

BACKGROUND Desonide, a class 6 nonfluorinated topical corticosteroid, has been available for more than two decades. Hydrocortisone is widely used in the treatment of dermatoses in children. OBJECTIVE Our purpose was to compare the safety and efficacy of desonide ointment and 1.0% hydrocortisone ointment in children with atopic dermatitis. METHODS One hundred thirteen children (mean age, 4.8 years) with mild to moderate atopic dermatitis were enrolled in a multicenter, randomized, investigator-masked, parallel-group study. Treatments were applied twice daily for 5 weeks and extended to 6 months in 36 of the patients. Signs of atrophy were evaluated. Efficacy was determined by measuring global improvement, erythema, lichenification, excoriations, oozing or crusting, pruritus, and induration. RESULTS No differences in safety were observed between hydrocortisone and desonide. The investigators global assessment of improvement significantly favored desonide over hydrocortisone during 3 months of treatment (p < 0.05). CONCLUSION Desonide ointment showed greater efficacy, produced more rapid improvement, and demonstrated an equivalent cutaneous safety profile when compared with 1% hydrocortisone ointment for up to 6 months.

Controlled evaluation of 0.05% desonide lotion and desonide cream in psoriasis

A new lotion formulation of 0.05% desonide was compared with its vehicle and with 0.05% desonide cream in a double-blind, randomized, parallel study in the treatment of psoriasis. Eighty patients with mild to moderate psoriasis, normally treatable with a low-potency topical corticosteroid, were enrolled in the study. All treatments were applied three times daily for up to 3 weeks, with weekly examinations. In both the lotion and cream treatment groups, 93% of patients completed the study. Only 75% of patients in the vehicle group completed the study. There was no statistically significant difference between the lotion and the cream at any of the three visits. Both treatments were well tolerated by the patients. Only 3 of 80 patients reported mild irritation, consisting of two cases of transient stinging and one of erythema without symptoms. Both active treatment groups showed significant improvement from baseline and over the vehicle group, reached a global improvement of 50% to 75% by weeks 2 and 3 compared with <50% improvement for the vehicle. The new lotion formulation of desonide is equivalent in both efficacy and safety to a 0.05% cream formulation and is convenient to apply over extended areas of the body.

Dermal safety comparison of 0.05% desonide cream and 1.0% hydrocortisone cream

Thirty patients with seborrheic dermatitis of the scalp were evaluated in this double-blind, randomized, bilateral study comparing 0.05% desonide cream with 1.0% hydrocortisone cream. Postauricular areas were treated twice daily for 8 weeks. Clinical evaluations at 1, 2, 4, 6, and 8 weeks included a quantitative assessment of telangiectasia; gradings of epidermal thinning, striae, and shiny surface appearance; and notation of presence or absence of hair loss, muscle waste, fat waste, loss of elasticity or skin markings, and purpura or bruising. No statistical differences were detected between the two products at the end of the 8-week treatment period. There were no signs of atrophy caused by either corticosteroid. The total number of telangiectasia, while few in number, was greater on the hydrocortisone-treated sites than on the desonide-treated sites.

Controlled, bilateral, comparative evaluation of 0.05% desonide lotion and desonide cream in eczematous dermatitis

Abstract A new lotion formulation of 0.05% desonide was compared with 0.05% desonide cream in a single (investigator)-blind, randomized, paired bilateral comparison study in the treatment of eczematous dermatitis. Eighteen patients with bilateral dermatitis, who would normally be treated with a low- to mid-potency topical corticosteroid, were eligible for entry into the study. A 7-day washout period was required for any potentially interfering therapy. Both treatments were given three times daily for up to 3 weeks. Patients were seen at study entry (baseline), and at 1, 2, and 3 weeks of treatment. Fifteen (83%) of the 18 patients completed the study. Of those, 12 patients completed all 3 weeks of treatment and 3 patients cleared bilaterally before week 3. Two patients were lost to follow-up and 1 patient whose condition worsened was dropped from the study early in order to receive alternative treatment. The overall mean severity score was significantly decreased ( P = 0.0002) for both the lotion and the cream from moderate at baseline to mild, with no statistically significant differences between the two treatments. Few patients experienced stinging or burning (4 of 18) or general irritation (2 of 18). Based on the results of this study, we conclude that desonide lotion is a safe and effective medication for treating the signs and symptoms of eczematous dermatitis and is equal in efficacy to desonide in a cream formulation.

Evaluating the efficacy of benzoyl peroxide wash

Clinical Pharmacology & Therapeutics (1996) 59, 167–167; doi: 10.1038/sj.clpt.1996.167