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Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis.This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments.Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle.This study was conducted in a relatively small population under controlled clinical trial conditions.Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

Brimonidine tartrate (BT) 0.5% gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea.To assess the 30-minute speed of onset of topical BT 0.5% gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema.Two Phase III, randomized, controlled studies with identical design in which subjects with moderate erythema of rosacea (study A: n=260; study B: n=293) were randomized 1:1 to apply topical BT 0.5% or vehicle gel once-daily for 4 weeks. Evaluations included severity of erythema based on Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA) prior to study drug application and at 30 minutes after application on days 1, 15, and 29.97.7% and 96.6% of subjects reported normal study completion for studies A and B, respectively. The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5% gel compared to vehicle gel on visit days (day 1: 27.9 vs 6.9%, P0.001; day 15: 55.9 vs 21.1%, P0.001; Day 29: 58.3 vs 32.0%, P0.001 for BT 0.5% gel vs vehicle) in study A. Similar results were shown for study B.Once-daily topical BT gel 0.5% is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies.

Brimonidine tartrate, a highly selective α2-adrenergic receptor agonist with potent vasoconstrictive activity, was shown to reduce erythema of rosacea.To assess the efficacy and safety of topical brimonidine tartrate gel 0.5% for the treatment of erythema of rosacea.Both studies were randomized, double-blind, and vehicle-controlled, with identical design. Subjects with moderate to severe erythema of rosacea were randomized 1:1 to apply topical brimonidine tartrate gel 0.5% or vehicle gel once-daily for 4 weeks, followed by a 4-week follow-up phase. Evaluations included severity of erythema based on Clinician's Erythema Assessment and Patient's Self-Assessment, as well as adverse events.Topical brimonidine tartrate gel 0.5% was significantly more efficacious than vehicle gel throughout 12 hours on days 1, 15, and 29, with significant difference observed as early as 30 minutes after the first application on day 1 (all P.001). No tachyphylaxis, rebound or aggravation of other disease signs were observed. Slightly higher incidence of adverse events was observed for topical brimonidine tartrate gel 0.5% than for vehicle; however, most of the adverse events were dermatological, mild, and transient in nature.These data generated in controlled trials may be different from those in clinical practice.Once-daily brimonidine tartrate gel 0.5% has a good safety profile and provides significantly greater efficacy relative to vehicle gel for the treatment of moderate to severe erythema of rosacea, as early as 30 minutes after application.

Few long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects.

Dapsone gel 5%, a topical formulation of dapsone, was shown to deliver clinically effective doses of dapsone with minimal systemic absorption in 2 randomized, vehicle-controlled, 12-week studies of patients with acne vulgaris. A 12-month, open-label, long-term safety study further evaluated the safety and efficacy of dapsone gel. Patients at least 12 years of age with acne vulgaris (N = 486) applied dapsone gel twice daily for up to 12 months. Application site reactions related to treatment were reported in 8.2% of the patients and were mostly mild to moderate in severity. Common nonapplication site adverse events included headache (20%) and nasopharyngitis (15%). No significant changes in hematology or blood chemistry parameters were observed. At one month, mean reduction from baseline in inflammatory lesion counts was 30.6%. At 12 months, mean reduction from baseline was 58.2%, 19.5%, and 49.0% for inflammatory, noninflammatory, and total lesion counts, respectively, (all P=.002 compared to baseline). These results show that dapsone gel 5% is safe and effective for long-term treatment of acne vulgaris and has a rapid onset of action.

This was a 12-month extension of a randomized, investigator-blinded, multicenter, 8-week trial with triple combination (TC) cream in facial melasma. A total of 585 patients were enrolled in the study and 569 patients received study medication. Three hundred eighty-nine patients completed 6 months of treatment and 327 patients completed 12 months of treatment. TC cream demonstrated a favorable safety profile: only 14 patients (2.5%) discontinued the study due to treatment-related adverse events (AEs). The 2 cases of skin atrophy were mild and did not lead to withdrawal. From the 23 cases of mild telangiectasia, only 2 resulted in discontinuation. All others were transient. Results confirmed those of a previous smaller study, with both physicians and patients reporting clinically significant improvements in melasma. By month 12, 80% of patients had lesions completely cleared or nearly cleared. Once daily application of TC cream applied intermittently over a long period is a safe, tolerable, and effective treatment for moderate to severe melasma of the face.

Topical acne therapies are widely used for the treatment of mild to moderately severe acne vulgaris. However, many available treatments have limitations associated with their use, including lengthy time to response, cosmetic acceptability, and photosensitivity. Combinations of topical antibiotics and comedolytics are especially useful, but some formulations have stability challenges. A new combination formulation that contains 1% clindamycin and 5% benzoyl peroxide (BenzaClin Topical Gel) is currently available. In clinical trials, clinical improvement occurred at the first two follow-up visits and continued throughout treatment. In addition, combination therapy with clindamycin/benzoyl peroxide gel rapidly reduces Propionibacteria acnes counts and suppresses the emergence of clindamycin-resistant P. acnes. This formulation is stable at room temperature for up to 2 months after compounding. The aqueous gel vehicle is less drying, and there is no photosensitivity associated with its use. This study compares the combination treatment of 1% clindamycin and 5% benzoyl peroxide topical gel with other therapeutic options for mild to moderately severe acne vulgaris.