- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650881
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
May 18, 2020 updated by: NYU Langone Health
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neutrogena ® Light Therapy Acne Mask (MASK)
Over-the-counter powered light-based device for the treatment of acne
|
Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes
|
Active Comparator: Topical benzoyl peroxide 2.5% gel and OTC adapalene
Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in the Investigator Global Assessment (IGA)
Time Frame: 12 Weeks
|
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
Time Frame: 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).
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2018
Primary Completion (Actual)
February 5, 2020
Study Completion (Actual)
February 5, 2020
Study Registration Dates
First Submitted
August 27, 2018
First Submitted That Met QC Criteria
August 27, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 20, 2020
Last Update Submitted That Met QC Criteria
May 18, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Dermatologic Agents
- Benzoyl Peroxide
- Adapalene
Other Study ID Numbers
- 17-01725
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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