A Prospective, Multicenter, Study of Laser-Activated Gold Microparticles for Treating Patients Using Concomitant Topical Retinoids for Mild-to-Moderate Inflammatory Acne.

Gold microparticles are indicated as an accessory to 1064 nm lasers to facilitate photo-thermal heating of sebaceous glands for treating mild-to-moderate inflammatory acne vulgaris (Sebacia Microparticles, Coronado Aesthetics LLC, Southlake, TX). The following study assessed the safety and clinical benefit of gold microparticles/laser therapy when used together with commercially available topical acne products. Healthy patients, 12 to 45 years old with mild-to-moderate inflammatory facial acne were prescribed a topical pre-treatment retinoid for 3 to 4 weeks. The gold microparticle suspension was then applied to the entire face and massaged into the skin. The laser procedure was performed with commercially available 1064 nm Nd:YAG lasers with fluence in the 20 to 35 J/cm2 range, a 30 ms pulse duration, and direct cooling. Among participants completing the study (N=52), the mean percent change in inflammatory lesion counts (ILC) was -55% at month 2, reaching -68% at month 12. At that time, 86% of participants achieved a 40% decrease in ILC and 75% achieved a 60% decrease in ILC. Mean Investigator's Global Assessment (IGA) Scale scores decreased by 41.6% from 2.4 at day 0 to 1.4 at month 12. The percentage of participants with clear or almost clear skin increased from 7% at day 0 to 59% at month 12. Acne therapy with topically applied gold microparticles followed by 1064 nm laser irradiation is an effective treatment for moderate to moderately severe acne. The treatment was well-tolerated with a high degree of participant satisfaction. J Drugs Dermatol. 2023;22(11):1088-1094     doi:10.36849/JDD.7744.

Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: Second of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-Controlled Trials.

BACKGROUND: Dapsone gel, 5% is administered twice daily for the treatment of acne vulgaris, and some patients may find adherence challenging.
OBJECTIVE: The study objective was to assess the efficacy and safety, compared with vehicle, of acne treatment with a recently FDA-approved, once-daily formulation of dapsone gel, 7.5%, with a 50% greater concentration of dapsone.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients aged 12 years and older with 20-50 facial inflammatory lesions, 30-100 facial noninflammatory lesions, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized (1:1 ratio) to topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with a GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2238 patients (1118 in the dapsone gel, 7.5% group and 1120 in the vehicle group). The GAAS success rates were 29.8% for the dapsone gel, 7.5% group and 20.9% for the vehicle group (P<0.001) at week 12. At week 12, mean inflammatory lesions decreased from baseline by 53.8% and 47.3%, noninflammatory lesions decreased by 45.9% and 40.4%, and total lesions decreased by 48.9% and 43.2% for the dapsone gel, 7.5% group and the vehicle group, respectively (all, P<0.001). The incidence of treatment-emergent adverse events was similar for dapsone gel, 7.5% (17.6%) and vehicle (17.1%). Most adverse events were mild to moderate in severity. The most frequently reported increase in severity for all of the dermal tolerability scales was from "none" to "mild."
CONCLUSION: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne vulgaris. Improvements in acne severity and lesions were observed over the 12-week course of treatment.

J Drugs Dermatol. 2016;15(8):962-969.

Long-term control of mycosis fungoides of the hands with topical bexarotene.

BACKGROUND: Limited Stage IA mycosis fungoides (MF) is often treated with topical steroids, which can cause atrophy, or with nitrogen mustard, which imposes several limitations on the patient's lifestyle. Topical bexarotene is a novel synthetic rexinoid with few side-effects that has shown efficacy for treatment of mycosis fungoides skin lesions in recent Phase II-III clinical trials. The Phase I-II trial involving 67 stage IA-IIA MF patients demonstrated complete response (CR) in 21% and partial response (PR) in 42% of the patients. The median time to response was approximately 20 weeks. In the phase III trial of refractory stage IA, IB and IIA MF, the patients demonstrated a 44% response rate (8% CR). Patients with no prior therapy for mycosis fungoides responded at a higher rate (75%) than those with prior topical therapies. METHODS: Case report of a patient with MF limited to the hands treated with topical bexarotene 0.1% gel in a open label phase II clinical trial. RESULTS: Partial response occurred after 2 weeks of topical bexarotene therapy and the lesions were well controlled for 5 years using bexarotene monotherapy, with only occasional mild local irritation. CONCLUSIONS: Topical bexarotene is effective as long-term treatment monotherapy for limited MF lesions. To our knowledge this is the longest use of the drug by any individual.