Acne
Conditions
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.
Interventions
DRUGNeutrogena ® Light Therapy Acne Mask (MASK)
Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes
DRUGTopical 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
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the Investigator Global Assessment (IGA) | 12 Weeks | 5 point assessment tool used to measure inflammation caused by acne |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Acne Q4 quality of life index score | 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). |
Outcome results
None listed