The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne

• Status: Withdrawn
• Trial end date: 2020-02-05
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Adapalene; Benzoyl Peroxide

Criteria

Inclusion Criteria:

• Diagnosis of acne vulgaris as determined by the study physician

• Mild-to-moderate acne defined as a grade 2 or 3 on the FDA Investigator Global Acne Assessment (IGA) for Acne vulgaris (Appendix 1)19

• If female,

• Negative urine pregnancy test at the time of enrollment and negative urine pregnancy tests at follow up visits

• Agreement to comply with medically acceptable forms of birth control with heterosexual intercourse

• Agreement to comply with the study protocol and attend all study visits

Exclusion Criteria:

• Is unwilling to participate in the survey

• Outside of specified age range

• Patients with clear, almost clear acne, or severe acne defined as grade 0-1 or 4 on the IGA Scale

• Females who are pregnant or breastfeeding

• Known allergy to any ingredients in the test products or history of photosensitivity

• Pre-existing facial dermatologic conditions including excoriations that could interfere with the outcome of this study and quantification of acne lesions

• Excessive facial hair or scarring that could interfere with quantification of acne lesions

• Does not have decision making capacity