Phase 4
N=50
Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02589405 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants Satisfied and Very Satisfied With Regimen — 42 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Benzoyl Peroxide (Drug); Dermotivin® Soft Liquid cleanser (Other); Cetaphil® Dermacontrol Moisturizer SPF30 (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Satisfied and Very Satisfied With Regimen |
42 | — |
Summary
The aim of this study is to evaluate a complete acne regimen consisting of a medication (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil® Dermacontrol Moisturizer SPF30 in patients with acne.
Eligibility Criteria
Inclusion Criteria
- Male or female subject of any ethnic background of 12 years or older.
- Subject with mild or moderate facial acne vulgaris defined as an Investigator Global Assessment (IGA) score at 2 or 3 on a 0-4 scale.
- Subject with any skin phototype according to T.B. Fitzpatrick skin phototype definitions.
Exclusion Criteria
- Subject with severe acne (IGA>3) with nodules, cysts, scars or extra-facial lesions,
- Female subject who is pregnant, lactating or planning a pregnancy during the study,
- Subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face,
Data sourced from ClinicalTrials.gov (NCT02589405). 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.