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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acne

Intervention / Treatment
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* Drug: Neutrogena ® Light Therapy Acne Mask (MASK)
* Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neutrogena ® Light Therapy Acne Mask (MASK)<br>Over-the-counter powered light-based device for the treatment of acne | Drug: Neutrogena ® Light Therapy Acne Mask (MASK)<br>* Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes<br>|
| Active Comparator: Topical benzoyl peroxide 2.5% gel and OTC adapalene<br>Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel | Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the Investigator Global Assessment (IGA) | 5 point assessment tool used to measure inflammation caused by acne | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Acne Q4 quality of life index score | 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). | 12 Weeks |