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

• ClinicalTrials.gov Identifier: NCT03650881
• Recruitment Status: Withdrawn
• First Posted: August 29, 2018
• Last Update Posted: May 20, 2020
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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
• Actual Study Start Date: August 7, 2018
• Actual Primary Completion Date: February 5, 2020
• Actual Study Completion Date: February 5, 2020

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03650881
• Other Study ID Numbers: 17-01725
• First Posted: August 29, 2018
• Last Update Posted: May 20, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Adapalene; Benzoyl Peroxide; 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