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

NCT ID: NCT03650881

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2020-02-05

Brief 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.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neutrogena ® Light Therapy Acne Mask (MASK)

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

Group Type: EXPERIMENTAL

Neutrogena ® Light Therapy Acne Mask (MASK)

Intervention Type: DRUG

Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes

Topical benzoyl peroxide 2.5% gel and OTC adapalene

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

Group Type: ACTIVE_COMPARATOR

Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene

Intervention Type: DRUG

Daily treatment with Reference Therapy OTC topical generic benzoyl peroxide 2.5% gel in the morning and OTC generic adapalene 0.1% gel at night

Interventions

Neutrogena ® Light Therapy Acne Mask (MASK)

Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes

Intervention Type: DRUG

Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene

Daily treatment with Reference Therapy OTC topical generic benzoyl peroxide 2.5% gel in the morning and OTC generic adapalene 0.1% gel at night

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

17-01725

Identifier Type: -

Identifier Source: org_study_id