Study Stopped
no eligible subjects were enrolled
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2018
CompletedFirst Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2020
CompletedMay 20, 2020
May 1, 2020
1.5 years
August 27, 2018
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change in the Investigator Global Assessment (IGA)
5 point assessment tool used to measure inflammation caused by acne
12 Weeks
Secondary Outcomes (1)
change in Acne Q4 quality of life index score
12 Weeks
Study Arms (2)
Neutrogena ® Light Therapy Acne Mask (MASK)
EXPERIMENTALOver-the-counter powered light-based device for the treatment of acne
Topical benzoyl peroxide 2.5% gel and OTC adapalene
ACTIVE COMPARATOROver-the-counter medication for the treatment of acne + 0.1% Adepalene Gel
Interventions
Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 29, 2018
Study Start
August 7, 2018
Primary Completion
February 5, 2020
Study Completion
February 5, 2020
Last Updated
May 20, 2020
Record last verified: 2020-05