Janet G. Hickman

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.

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

A bstractBackground: 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 ? 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 (?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.

Ketoconazole 2% shampoo in the treatment of tinea versicolor: A multicenter, randomized, double-blind, placebo-controlled trial

BACKGROUND Tinea versicolor is a common superficial fungal infection caused by a lipophilic yeast. This chronically recurring opportunistic infection is especially prevalent in tropical and semitropical regions. The topical short-term application of ketoconazole 2% shampoo may provide effective and safe therapy for tinea versicolor. OBJECTIVE The purpose of this study was to evaluate the efficacy and safety of a single application (1 day) versus three daily applications (3 days) of ketoconazole 2% shampoo versus placebo shampoo in the treatment of mycologically confirmed tinea versicolor. METHODS Three hundred twelve patients were included in the primary analyses for this 31-day study. Global evaluation scores were measured on days 10 and 31 with a 5-point scale (1 = healed to 5 = worsening), and a cellophane tape test was done at baseline and days 3, 10, and 31. Efficacy was assessed by clinical response, defined as both a global evaluation score of 1 (healed) and a negative cellophane tape test on day 31. Signs and symptoms of tinea versicolor (scaling, itching, erythema, hypopigmentation, hyperpigmentation) also were evaluated at baseline, day 10, and day 31 with a 4-point scale (0 = absent to 3 = severe). RESULTS Both regimens of ketoconazole shampoo were significantly (P < .001) more effective than placebo for rate of clinical response, global evaluation scores, and mycologic outcomes (cellophane tape test). The clinical response rates at day 31 were 73%, 69%, and 5% for the 3-day ketoconazole, 1-day ketoconazole, and placebo groups, respectively. The difference in the efficacy of the two ketoconazole treatment regimens was not statistically significant. There were no significant differences between any of the treatment groups in the number of patients who experienced adverse events. No serious adverse events occurred and no patient withdrew from the trial prematurely because of an adverse event. CONCLUSION Ketoconazole 2% shampoo, used as a single application or daily for 3 days, is safe and highly effective in the treatment of tinea versicolor.

Long-term efficacy and safety of tretinoin emollient cream 0.05% in the treatment of photodamaged facial skin : A two-year, randomized, placebo-controlled trial

AbstractBackground: Long-term (>1 year) placebo-controlled studies of tretinoin in the treatment of photodamaged skin have not been conducted. Recently, we conducted a 2-year placebo-controlled study of tretinoin emollient cream 0.05%, including histopathologic assessment of safety and analysis of markers of collagen deposition. Objective: The objective of the study was to determine the long-term safety and efficacy of tretinoin emollient cream 0.05% in the treatment of moderate to severe facial photodamage. Methods: A total of 204 subjects were treated with tretinoin or placebo (vehicle emollient cream) applied to the entire face once a day for up to 2 years. Clinical and histologic effects were assessed at regularly scheduled clinic visits. Results: Treatment with tretinoin resulted in significantly greater improvement relative to placebo in clinical signs of photodamage (fine and coarse wrinkling, mottled hyperpigmentation, lentigines, and sallowness), overall photodamage severity, and investigator’s global assessment of clinical response (p < 0.05). Histologic evaluation showed no increase in keratinocytic or melanocytic atypia, dermal elastosis, or untoward effects on stratum corneum following treatment with tretinoin compared with placebo. Immunohistochemistry studies, conducted at three study centers, showed a significant increase relative to placebo in facial procollagen 1C terminal, a marker for procollagen synthesis, at month 12 (p = 0.0074). Conclusion: Long-term treatment with tretinoin emollient cream 0.05% is safe and effective in subjects with moderate to severe facial photodamage.

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 studys 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.

Therapeutic activity of lactate 12% lotion in the treatment of ichthyosis: Active versus vehicle and active versus a petrolatum cream

Lactate 12% lotion was significantly more effective than both its vehicle and a petrolatum-based cream in the treatment of ichthyosis. The treatment regimen was twice-daily application for 4 weeks with evaluations weekly during the treatment period and for 2 weeks after treatment was stopped. Vulgaris, lamellar, sex-linked, Nethertons, and epidermolytic hyperkeratotic forms of ichthyosis were significantly improved by treatment with lactate 12% lotion. This new therapeutic modality expands the scope and extent of ichthyotic conditions that may now be successfully treated.

Double-blind comparison of naftifine cream and clotrimazole/betamethasone dipropionate cream in the treatment of tinea pedis

chenoid infiltrate of lymphocytes. Immunofluorescence examination of a perivesicular papule was characterized by numerous ovoid bodies scattered in the papillary dermis. These stained for IgM, IgG, and fibrinogen. IgG, C3, and fibrinogen were also deposited linearly along the dermoepidermal junction. Immunofluorescence studies on normal-appearing skin showed a strong linear band of IgG and C3 at the dermoepidermal junction without staining of colloid bodies. Serum and blister fluid were positive at a titer of 1:80 for basement membrane zone (BMZ) antibodies. A diagnosis ofLPP was made. She was initially treated with prednisone, 40 mg daily (1.5 mg/kg/day), with a good response, no new vesicles appeared and the papular lesions cleared. After 2 weeks circulating BMZ antibodies decreased to a titer of 1:20. The dosage of prednisone was reduced to 20 mg daily for 14 days and then discontinued. Topical fluorinated corticoids were administered for an additional month. At that time she had resolution of all lesions. Two months later, she had a relapse of LP, without blistering, on both ankles. At the time of relapse circulating BMZ antibodies were absent.

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 (or 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 < 0.001), and they showed significantly better resolution of signs and symptoms. Statistically significant differences favoring naftifine over its vehicle were found throughout the treatment period and 2 weeks posttreatment.