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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

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ClinicalTrials.gov Identifier: NCT03650881
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Drug: Neutrogena ® Light Therapy Acne Mask (MASK) Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neutrogena ® Light Therapy Acne Mask (MASK)
Over-the-counter powered light-based device for the treatment of acne
Drug: Neutrogena ® Light Therapy Acne Mask (MASK)
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
Drug: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene
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 Measures :
  1. change in the Investigator Global Assessment (IGA) [ Time Frame: 12 Weeks ]
    5 point assessment tool used to measure inflammation caused by acne


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03650881     History of Changes
Other Study ID Numbers: 17-01725
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Benzoyl Peroxide
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents