N/A
N=117
A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02698436 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Percent Change of Global Face Total Acne Lesion Count From Baseline — -44; -54 Percent change of acne lesion count
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acne Mask (Device); 2.5% Benzoyl Peroxide Treatment (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change of Global Face Total Acne Lesion Count From Baseline |
-44; -54 | — |
| SECONDARY Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1 |
-19; -26 | — |
| SECONDARY Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2 |
-28; -42 | — |
| SECONDARY Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4 |
-35; -46 | — |
| SECONDARY Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8 |
-40; -50 | — |
| SECONDARY Acne Lesion Counts Total Global Face - Baseline |
47.2; 47.6 | — |
| SECONDARY Acne Lesion Counts Total Global Face - Week 1 |
39.2; 36.8 | — |
| SECONDARY Acne Lesion Counts Total Global Face - Week 2 |
35.3; 30.5 | — |
| SECONDARY Acne Lesion Counts Total Global Face - Week 4 |
30.5; 27.0 | — |
| SECONDARY Acne Lesion Counts Total Global Face - Week 8 |
27.8; 26.4 | — |
| SECONDARY Acne Lesion Counts Total Global Face - Week 12 |
24.8; 23.3 | — |
| SECONDARY Investigator Global Acne Assessment - Baseline |
2.55; 2.51 | — |
| SECONDARY Investigator Global Acne Assessment - Week 1 |
2.35; 2.34 | — |
| SECONDARY Investigator Global Acne Assessment - Week 2 |
2.23; 2.11 | — |
| SECONDARY Investigator Global Acne Assessment - Week 4 |
2.08; 1.87 | — |
| SECONDARY Investigator Global Acne Assessment - Week 8 |
1.88; 1.70 | — |
| SECONDARY Investigator Global Acne Assessment - Week 12 |
1.77; 1.59 | — |
Summary
This study will compare two different acne treatments for the treatment of acne. Half of the participants will receive two marketed acne products (cleanser and leave-on topical treatment), while the other half of the participants will receive a marketed cleanser and a light-therapy device.
Eligibility Criteria
Inclusion Criteria
- Has mild to moderate acne
- Has 10 - 100 pimples, 10 - 50 inflamed red pimples, up to 2 raised bumps and no cysts
- In general good health
- Must avoid excessive sun exposure and any light treatments or any professional or aesthetic spa-like procedures
- Must not be pregnant, nursing or intend to become pregnant during the study
- Must agree to practice a medically acceptable form of birth control.
- Must be able to read, speak, write and understand English
Exclusion Criteria
- Allergies or sensitivities to product ingredients or to light
- Has severe acne or pre-existing dermatological facial condition
- Has an uncontrolled disease or immune deficient disorder
- Is pregnant, breast-feeding or intending to become pregnant
- Has been taking prescription drug medication for acne or antibiotics for the past 6 months
Data sourced from ClinicalTrials.gov (NCT02698436). 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.