Effect of NFX-179 MEK inhibitor on cutaneous neurofibromas in persons with neurofibromatosis type 1.

This phase 2a trial investigated the efficacy of NFX-179 Topical Gel, a metabolically labile MEK inhibitor, in the treatment of cutaneous neurofibromas (cNFs) in neurofibromatosis type 1. Forty-eight participants were randomized to four treatment arms: NFX-179 Topical Gel 0.05%, 0.

Once-daily roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase IIb study.

Background: Scalp psoriasis affects most patients with psoriasis, but it can be difficult to treat.

Objectives: To evaluate the efficacy and safety of once-daily roflumilast foam 0.3% on scalp and body psoriasis.

Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial.

Background: Itch is the most bothersome symptom reported by patients with psoriasis. Safe and effective treatments for psoriasis that also address itch are needed.

Objectives: To report effects of roflumilast cream on itch-related outcomes from a Phase 2b trial.

Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials.

Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.

Objective: To evaluate the efficacy of roflumilast cream, 0.

Phase 2 randomized, dose-ranging trial of CTP-543, a selective Janus Kinase inhibitor, in moderate-to-severe alopecia areata.

Background: Janus kinase (JAK) activation is suggested to have a pathological role in alopecia areata (AA). CTP-543, a deuterated compound that selectively inhibits JAK1 and JAK2, is being developed as an oral treatment for AA.

Objective: To assess the safety and efficacy of a 24-week regimen of CTP-543 in patients with chronic, moderate-to-severe AA.

Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.

Background: The tubulin polymerization and Src kinase signaling inhibitor tirbanibulin is being investigated as a topical treatment for actinic keratosis, a precursor of squamous-cell carcinoma.

Methods: In two identically designed double-blind trials, we randomly assigned, in a 1:1 ratio, adults with actinic keratoses on the face or scalp to receive either topical tirbanibulin or vehicle (placebo) ointment. The ointment was applied by the patients to a 25-cm contiguous area containing four to eight lesions once daily for 5 consecutive days.

Trial of Roflumilast Cream for Chronic Plaque Psoriasis.

Background: Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis.

Methods: In this phase 2b, double-blind trial, we randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to use roflumilast 0.

Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: A randomized, multicenter, double-blind, vehicle-controlled phase 3 study.

Background: Onychomycosis is a recalcitrant fungal nail infection. Topical antifungal agents may be preferred over systemic agents due to lack of systemic adverse effects.

Objective: To investigate the efficacy and safety of topical terbinafine 10% solution (MOB-015) for the treatment of distal and lateral subungual onychomycosis.

A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities.

Background: Blue-light aminolevulinic acid photodynamic therapy (ALA-PDT) after broad-area application and 3-hour incubation is efficacious for actinic keratosis (AK) lesion clearance on upper extremities, with use of occlusive dressing significantly increasing efficacy.

Objective: To prove the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the spot treatment of multiple AKs on upper extremities.

Methods: Aminolevulinic acid or VEH was spot applied only to lesions on one upper extremity 3 hours before blue-light exposure.

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302).

Background: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need.

Objective: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK).

Methods: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle.

A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis.

Objective: To evaluate pimecrolimus cream 1% and tacrolimus ointment 0.03% in pediatric patients with moderate atopic dermatitis (AD).

Methods: 141 patients (aged 2-17 years) were randomized to treatment with pimecrolimus cream 1% (n=71) or tacrolimus ointment 0.

Effect of a desogestrel-containing oral contraceptive on the skin.

Objective: This pilot study evaluated the effects of a desogestrel-containing oral contraceptive (DSG-OC) on facial seborrhea (oiliness), acne and related factors in otherwise healthy women with moderate facial acne vulgaris.

Methods: In this double-blind, placebo-controlled study, 41 women received DSG-OC (50/100/150 microg desogestrel plus 35/30/30 microg ethinylestradiol given in a 7/7/7 day regimen) and 41 received placebo for six cycles. Seborrhea and skin assessments, and hormone analyses were performed regularly.

Drug interactions of the newer oral antifungal agents.

The newer oral antifungal agents, such as fluconazole, itraconazole and terbinafine, are generally both effective and well tolerated in the management of widespread or resistant dermatomycoses such as onychomycosis. However, these agents differ markedly in their potential to cause clinically significant drug interactions. Triazoles such as fluconazole and itraconazole have been responsible for a greater number of clinically significant drug interactions than terbinafine.

An evaluation of the effect of an alpha hydroxy acid-blend skin cream in the cosmetic improvement of symptoms of moderate to severe xerosis, epidermolytic hyperkeratosis, and ichthyosis.

A number of genetic, intrinsic, and extrinsic factors can cause conditions of problem dry skin, marked by unusual dryness, rough texture, and extreme flaking and scaling, that are generally not controlled by conventional moisturizers. A study was undertaken to evaluate the safety and efficacy of two novel alpha hydroxy acid (AHA)-containing creams in reducing the appearance and symptoms of problem dry skin on subjects with a range of dry skin conditions, including xerosis, epidermolytic hyperkeratosis, and ichthyosis. Twenty subjects completed a course of treatment with either regular or extra strength AHA-blend cream on a test site, compared with a currently marketed, non-AHA moisturizing lotion on a control site.

Efficacy and safety of twice-daily augmented betamethasone dipropionate lotion versus clobetasol propionate solution in patients with moderate-to-severe scalp psoriasis.

This 2-week, randomized, multicenter, investigator-blinded, parallel-group study was conducted to compare the efficacy and safety of augmented betamethasone dipropionate 0.05% lotion and clobetasol propionate 0.05% solution in the treatment of moderate-to-severe scalp psoriasis among 197 (193 assessable) healthy adult patients with at least 20% scalp-surface involvement.

Intermittent corticosteroid maintenance treatment of psoriasis: a double-blind multicenter trial of augmented betamethasone dipropionate ointment in a pulse dose treatment regimen.

Ninety psoriasis patients, who were either completely cleared of or manifested only a minimal presence of disease signs following 3-4 weeks of twice daily treatment with augmented betamethasone dipropionate (ABD) ointment 0.05%, were enrolled in this multicenter, double-blind, placebo-controlled study. The study was designed to determine if an intermittent pulse dose regimen of ABD ointment could safely and effectively maintain a remission disease status when treatment was applied in three consecutive applications 12 h apart, once a week for a maximum treatment period of 6 months.

Preatrophy: covert sign of thinned skin.

Overt iatrogenic cutaneous atrophy is easily recognized; however, the earliest signs of such an adverse event may be covert. Preatrophy is proposed as a term to describe the subtle unmasking or normally covert subpapillary vascular channels found by the use of enhanced skin surface magnification techniques. We conducted a randomized double-blind, bilaterally paired comparison clinical trial in patients with chronic plaque psoriasis treated with twice-daily (nonoccluded) superpotent topical steroids for 2 weeks.

Betamethasone dipropionate in optimized vehicle. Intermittent pulse dosing for extended maintenance treatment of psoriasis.

A study was done of extended maintenance therapy using either betamethasone dipropionate (Diprolene) in optimized vehicle (OV) (ointment) or placebo in patients with psoriasis vulgaris. Of 59 patients originally enrolled in the study, 38 assessable patients achieved clearing of at least 85% improvement from baseline with traditional betamethasone in OV twice a day for two to three weeks before intermittent pulse dosing was attempted. Thereafter, the test medication was used on weekends (three consecutive doses at 12-hour intervals) once a week.