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

Acne Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03650881
• Other study ID #: 17-01725
• Status: Withdrawn
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Neutrogena ® Light Therapy Acne Mask (MASK)
Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the Investigator Global Assessment (IGA)	5 point assessment tool used to measure inflammation caused by acne	12 Weeks
Secondary	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).	12 Weeks