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

NYU Langone Health

Status: Withdrawn

Conditions: Acne

Treatments: Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene; Drug: Neutrogena ® Light Therapy Acne Mask (MASK)

Study type: Interventional

Funder types: Other

Identifiers

NCT03650881

17-01725

Details and patient eligibility

About

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.

Sex: All

Ages: 12 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Neutrogena ® Light Therapy Acne Mask (MASK)

Experimental group

Description:

Over-the-counter powered light-based device for the treatment of acne

Treatment:

Drug: Neutrogena ® Light Therapy Acne Mask (MASK)

Topical benzoyl peroxide 2.5% gel and OTC adapalene

Active Comparator group

Description:

Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel

Treatment:

Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene