Back to resultsThe 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
Primary Purpose
Acne
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neutrogena ® Light Therapy Acne Mask (MASK)
Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene
Sponsored by
About this trial
This is an interventional treatment trial for Acne
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neutrogena ® Light Therapy Acne Mask (MASK)
Topical benzoyl peroxide 2.5% gel and OTC adapalene
Arm Description
Over-the-counter powered light-based device for the treatment of acne
Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel
Outcomes
Primary Outcome Measures
change in the Investigator Global Assessment (IGA)
5 point assessment tool used to measure inflammation caused by acne
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03650881
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no eligible subjects were enrolled
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neutrogena ® Light Therapy Acne Mask (MASK)
Arm Type
Experimental
Arm Description
Over-the-counter powered light-based device for the treatment of acne
Arm Title
Topical benzoyl peroxide 2.5% gel and OTC adapalene
Arm Type
Active Comparator
Arm Description
Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel
Intervention Type
Drug
Intervention Name(s)
Neutrogena ® Light Therapy Acne Mask (MASK)
Intervention Description
Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes
Intervention Type
Drug
Intervention Name(s)
Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene
Intervention Description
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
Primary Outcome Measure Information:
Title
change in the Investigator Global Assessment (IGA)
Description
5 point assessment tool used to measure inflammation caused by acne
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
change in Acne Q4 quality of life index score
Description
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).
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
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
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