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

Not Applicable

Withdrawn

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

• Registration Number: NCT03650881
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-07
• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutrogena ® Light Therapy Acne Mask (MASK)	Neutrogena ® Light Therapy Acne Mask (MASK)	Over-the-counter powered light-based device for the treatment of acne
Topical benzoyl peroxide 2.5% gel and OTC adapalene	Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene	Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel

Primary Outcome Measures

Name	Time	Method
change in the Investigator Global Assessment (IGA)	12 Weeks	5 point assessment tool used to measure inflammation caused by acne

Secondary Outcome Measures

Name	Time	Method
change in Acne Q4 quality of life index score	12 Weeks	The Acne-QoL contains 19 questions organized into four domains (self-perception, role-social, roleemotional, and acne symptoms) which refer to facial acne. For all domains, higher scores reflect better HRQoL. The total score varies from zero to 114, distributed as follows: 0- 30 (self-perception), 0-24 (role-social), 0-30 (role-emotional), and 0-30 (acne symptoms).