The efficacy and safety of a combination benzoyl peroxide/clindamycin topical gel compared with benzoyl peroxide alone and a benzoyl peroxide/erythromycin combination product.

BACKGROUND: Topical clindamycin and benzoyl peroxide have each demonstrated clinical efficacy in the treatment of acne vulgaris. When used in tandem, they promise greater efficacy than either individual agent through their antibacterial and anti-inflammatory effects. OBJECTIVE: To determine the efficacy and safety of combination benzoyl peroxide/ clindamycin compared with benzoyl peroxide or benzoyl peroxide/erythromycin in the treatment of acne. METHODS: In this randomized, 10-week, multicenter, single-blind trial, 492 patients with moderate to moderately severe acne were treated twice daily with 5% benzoyl peroxide/1% clindamycin, 5% benzoyl peroxide, or 5% benzoyl peroxide/3% erythromycin and assessed every 2 weeks. RESULTS: Compared with benzoyl peroxide, benzoyl peroxide/clindamycin demonstrated significantly greater reductions in inflammatory lesions (p = 0.04) and significantly greater overall improvement as assessed by physicians (p < or = 0.04) and patients (p < 0.001). Benzoyl peroxide/clindamycin demonstrated a nonsignificant trend for greater efficacy compared to benzoyl peroxide/erythromycin. Dry skin was the most frequent (< or = 7.3%) adverse event with all three therapies. CONCLUSION: Benzoyl peroxide/clindamycin demonstrated improved efficacy and similar tolerability; to benzoyl peroxide used alone and was similar to benzoyl peroxide/ erythromycin, making this combination product an effective alternative antimicrobial therapy for acne.

Human dermal safety studies with eflornithine HCl 13.9% cream (Vaniqa), a novel treatment for excessive facial hair.

Eflornithine HCl 13.9% cream (Vaniqa) is a novel treatment for the management of unwanted facial hair in women. This paper reports the results of four modified open-label, within-subject vehicle-controlled studies evaluating the dermal safety of this topical treatment. In a repeated insult patch test (230 subjects), erythema with oedema occurred in 38.9% of subjects treated with eflornithine HCl 13.9% cream and 4.8% of subjects treated with vehicle cream. Challenge applications at previously untested sites following the three-week induction period produced noticeable erythema or greater on only four sites treated with eflornithine HCl 13.9% cream and one vehicle-treated site. The erythema at these sites subsided substantially within 24 hours. In a three-week cumulative irritation study (30 subjects), the mean irritation score for sites treated with eflornithine HCl 13.9% cream was 1.33, compared with 0.76 at vehicle-treated sites and 3.09 at positive-control (sodium lauryl sulphate-treated) sites (p < 0.001 between all three groups). In a phototoxicity study (25 subjects), irradiated sites showed either no reaction (40% of both sites treated with eflornithine HCl 13.9% cream and vehicle-treated sites), or mild erythema subsiding in all cases but one within 24 hours. No reaction was seen at non-irradiated sites. In a photocontact allergy study (30 subjects), challenge with eflornithine HCl 13.9% cream or its vehicle alone produced either no reaction or mild erythema subsiding within 24 hours at both irradiated and non-irradiated sites. No serious adverse events were reported during the studies, and the only adverse events considered related to treatment were pruritus (three subjects) and dry skin at test site (one subject). These results demonstrate that eflornithine HCl 13.9% cream does not have contact sensitising, photocontact allergic or phototoxic properties. It can cause irritation under exaggerated conditions of use. Eflornithine HCl 13.9% cream, therefore, has a favourable dermal safety profile appropriate for a topical treatment to be applied routinely.

Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study.

Retinoids reverse the abnormal pattern of keratinization seen in acne vulgaris. Tazarotene is the first of a novel family of topical receptor-selective acetylenic retinoids. This study evaluates the safety and efficacy of topical tazarotene 0.1% and 0.05% gels, in comparison to vehicle gel, applied once daily for 12 weeks, in the treatment of mild-to-moderate facial acne vulgaris. A total of 446 patients with facial acne vulgaris were enrolled, and 375 patients, ranging in age from 14 to 44 years, were evaluable in this multicenter, double-blind, randomized study. In comparison to vehicle gel, treatment with tazarotene 0.1% gel resulted in significantly greater reductions in noninflammatory and total lesion counts at all follow-up visits, and inflammatory lesion counts at Week 12. Tazarotene 0.05% gel resulted in significantly greater reductions in noninflammatory and total lesion counts than vehicle gel at Weeks 8 and 12. At Week 12, treatment success rates were 68% and 51% for tazarotene 0.1% and 0.05%, respectively (40% for vehicle gel). Tazarotene gel was an effective, safe, and generally well-tolerated therapy for the treatment of acne vulgaris.

A double-blind, randomized, placebo-controlled evaluation of short-term treatment with oral itraconazole in patients with tinea versicolor.

BACKGROUND: The use of short-term oral azoles is an alternative to topical therapy in patients with tinea versicolor. OBJECTIVE: We compared the efficacy and safety of oral itraconazole with that of placebo in 36 patients with mycologically proven tinea versicolor. METHODS: Patients were randomly assigned to 7 days of treatment with either itraconazole, 200 mg once daily, or placebo. A potassium hydroxide examination and assessment of scaling, erythema, pruritus, and global condition were performed at baseline and at 4 weeks after treatment. RESULTS: The itraconazole-treated group demonstrated significant improvement over both baseline (p < 0.01) and placebo (p < 0.02) in scaling, erythema, and pruritus. Sixty-seven percent of itraconazole-treated patients were free of symptoms at week 5, as compared with 12% of placebo-treated patients. Ninety-four percent of itraconazole-treated patients were considered to be healed or markedly improved at the study's end point compared with 6% of placebo-treated patients (p < 0.01). A total of 89% in the itraconazole-treated group had a negative potassium hydroxide examination at the follow-up visit compared with 6% in the placebo-treated group (p < 0.01). There was a single report of a possibly treatment-related adverse event in each treatment group. CONCLUSION: Short-term treatment with itraconazole is effective and well tolerated in the management of tinea versicolor.

A double-blind, vehicle-controlled study of clobetasol propionate 0.05% (Temovate) scalp application in the treatment of moderate to severe scalp psoriasis.

The efficacy and safety of clobetasol propionate 0.05% scalp application was evaluated in 378 patients with moderate to severe scalp psoriasis in a double-blind vehicle-controlled parallel group study. After 2 weeks of twice-daily applications, 81% receiving active drug versus 22% receiving vehicle had clearing of 50% or greater. Complete clearing was seen in 26% with active drug and 1% with vehicle. Local side effects were primarily burning or stinging in 11% and 10% of patients treated on an active or a vehicle regimen, respectively. The morning cortisol levels of 168 patients were checked at baseline and again after 2 weeks of drug therapy. Subnormal morning plasma cortisol values were seen in 5% of the patients receiving active drug and in 5% receiving vehicle; 13% of those taking active drug versus 5% taking vehicle had a 50% or greater decrease in morning cortisol at the 2-week visit compared with baseline values. Clobetasol propionate 0.05% scalp application appears to be a safe and an effective treatment for scalp psoriasis.

Once-daily naftifine cream 1% in the treatment of tinea cruris and tinea corporis.

Seventy patients with tinea cruris or tinea corporis were treated with naftifine cream 1% or vehicle once daily for 4 weeks in this double-blind, randomized study. After two weeks, the patients using naftifine had a significantly higher mycologic cure rate than the vehicle-treated patients (79% vs. 31%, p less than 0.001), and they showed significantly better resolution of signs and symptoms. Statistically significantly differences favoring naftifine over its vehicle were found throughout the treatment period and 2 weeks posttreatment.

Pyoderma gangrenosum.

Since its description 50 years ago, pyoderma gangrenosum has continued to capture the attention and imagination of all those who see its dramatic presentation. Clinical observation still provides the only reliable diagnosis. As investigative techniques increase, more and more intriguing immunologic abnormalities associated with this disorder are discovered, but understanding of the pathogenesis remains elusive. It is now recognized as an independent condition as well as a co-condition with many systemic disorders. Many new treatment options are available, allowing much individualization of treatment. For now, pyoderma gangrenosum remains an impressive, relatively easily recognized, but poorly understood disease.

Aseptic (avascular) necrosis of the femoral head in psoriasis.

Aseptic (avascular) necrosis of the femoral head associated with psoriasis is reported. The clinical histories of nine patients with avascular necrosis of the femoral head and one patient with bilateral humeral head osteonecrosis are summarized. Psoriasis was the only associated condition found in three of the patients. Only two patients had received systemic corticosteroids in significant amounts (greater than 1 gm of prednisone). Four patients had received methotrexate therapy for psoriasis. Other possible contributing factors including serum uric acid levels are discussed. Psoriasis should be added to the list of systemic diseases associated with aseptic (avascular) necrosis. Avascular necrosis of the femoral head should be considered in any patient with psoriasis and pain in the hip or thigh.