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no eligible subjects were enrolled
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neutrogena ® Light Therapy Acne Mask (MASK) | Experimental | Over-the-counter powered light-based device for the treatment of acne |
|
| Topical benzoyl peroxide 2.5% gel and OTC adapalene | Active Comparator | Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutrogena ® Light Therapy Acne Mask (MASK) | Drug | Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in the Investigator Global Assessment (IGA) | 5 point assessment tool used to measure inflammation caused by acne | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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,
Agreement to comply with the study protocol and attend all study visits
Exclusion Criteria:
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| Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene | Drug | 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 |
|
| 12 Weeks |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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