A 6-month, Multi-center, Double-blind, Controlled Study to Evaluate the Effect of a Biofilm Disrupting Acne Cream on Mild-to-Moderate Facial Acne in Female Volunteer Subjects.

Autor:	Marshall-Hudson A; Drs. Marshall-Hudson, Tuley, and Dosik and Ms. Damstra are with TKL Research, Inc. in Fair Lawn, New Jersey., Tuley M; Drs. Marshall-Hudson, Tuley, and Dosik and Ms. Damstra are with TKL Research, Inc. in Fair Lawn, New Jersey., Damstra M; Drs. Marshall-Hudson, Tuley, and Dosik and Ms. Damstra are with TKL Research, Inc. in Fair Lawn, New Jersey., Dosik JS; Drs. Marshall-Hudson, Tuley, and Dosik and Ms. Damstra are with TKL Research, Inc. in Fair Lawn, New Jersey., Myntti MF; Dr. Myntti and Ms. Porral and Ms. Palomo are with Next Science, LLC in Jacksonville, Florida., Porral D; Dr. Myntti and Ms. Porral and Ms. Palomo are with Next Science, LLC in Jacksonville, Florida., Palomo J; Dr. Myntti and Ms. Porral and Ms. Palomo are with Next Science, LLC in Jacksonville, Florida.
Jazyk:	angličtina
Zdroj:	The Journal of clinical and aesthetic dermatology [J Clin Aesthet Dermatol] 2023 Apr; Vol. 16 (4), pp. 43-52.
Abstrakt:	Objectives: The primary aim of this study was to assess the change in acne lesions and severity within all treatment groups over the course of a six-month study. Methods: This was a six-month, multisite, randomized, double-blind, controlled study in female subjects with mild-to-moderate acne to assess the clinical and psychological outcomes of treatment with biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, 2.5% benzoyl peroxide (BPO) gel, and placebo. Subjects applied the assigned product to their face twice daily and were evaluated for clinical acne and quality of life outcomes at baseline and after six, 12, 18, and 24 weeks of treatment. Results: After 24 weeks of use, subjects treated with biofilm disrupting acne cream 2x had a significantly greater improvement in the Investigator Global Assessment (IGA), compared to those treated with 2.5% BPO gel. Based on dermatologic assessments, biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, and placebo control were associated with less erythema and dryness, compared to 2.5% BPO gel. Limitations: Assessments within this study had the potential for subjective differences due to variability between evaluators. Conclucion: Biofilm disrupting acne cream 2x and biofilm disrupting acne cream 1x provided equivalent efficacy to 2.5% BPO gel with less of the adverse effects commonly associated with BPO, such as erythema and dryness. Both the biofilm disrupting acne cream without salicylic acid and the placebo control were associated with mild improvements to acne symptoms over the course of the 24-week study. Trial Registry Information: ClinicalTrials.gov, NCT03106766. Competing Interests: DISCLOSURES: Dr. Myntti and Ms. Porral and Palomo are employees of Next Science, LLC. All other authors report no conflicts of interest relevant to the contents of this article. (Copyright © 2023. Matrix Medical Communications. All rights reserved.)
Databáze:	MEDLINE
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