N/A
N=45
A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT03128723 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Cutaneous Tolerance Scores: Erythema — -0.07 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acne Mask (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cutaneous Tolerance Scores: Erythema |
-0.09 | — |
| PRIMARY Cutaneous Tolerance Scores: Dryness/Scaling |
-0.11 | — |
| PRIMARY Cutaneous Tolerance Scores: Edema |
0.00 | — |
| PRIMARY Cutaneous Tolerance Scores: Burning/Stinging |
0.02 | — |
| PRIMARY Cutaneous Tolerance Scores: Itching |
0.04 | — |
| PRIMARY Cutaneous Tolerance Scores: Tightness/Dry Feeling |
-0.05 | — |
| SECONDARY Cutaneous Tolerance Scores: Erythema |
-0.09 | — |
| SECONDARY Cutaneous Tolerance Scores: Dryness/Scaling |
-0.11 | — |
| SECONDARY Cutaneous Tolerance Scores: Edema |
0.00 | — |
| SECONDARY Cutaneous Tolerance Scores: Burning/Stinging |
0.02 | — |
| SECONDARY Cutaneous Tolerance Scores: Itching |
0.04 | — |
| SECONDARY Cutaneous Tolerance Scores: Tightness/Dry |
-0.02 | — |
Summary
The study will look to evaluate the tolerance of a light therapy-based acne mask device in participants who report having sensitive skin. All participants will receive a cleanser, a light therapy mask, and an extra activator for the light therapy mask.
Eligibility Criteria
Inclusion Criteria
- In good general health
- Has mild to moderate facial acne
- Has sensitive skin per sensitive skin questionnaires
- Has score of "0" or "1" in all tolerance parameters (erythema, dryness/scaling, edema, burning/stinging, itching, and tightness/dryness feeling)
- Able to read, write, speak, and understand English
- Must agree to practice a medically acceptable form of birth control
Exclusion Criteria
- Has known light or photo-sensitivity disorder
- Has very sensitive skin or known allergies to skincare products or the cleanser ingredients
- Has severe acne or pre-existing facial skin conditions other than mild to moderate acne
- Females that are pregnant, nursing, or planning to become pregnant
- Males with a female partner who is pregnant or planning to become pregnant
- Has been using a product or medication that the investigator determines will increase health risk to the subject or confuse the study results
- Is participating or has participated in another study with the past 30 days
- Has history of immunosuppression/immune deficiency disorders
- Has planned surgeries or invasive medical procedures scheduled during the study
- Is related to the Sponsor, Investigator, or Study Site
Data sourced from ClinicalTrials.gov (NCT03128723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.