Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris
Benzac
Benzaknen® 5% Gel in Combination With Dermotivin® Soft Liquid Soap and Non-comedogenic Cetaphil® Dermacontrol Moisturizer SPF30 in the Treatment of Mild-to-moderate Acne Vulgaris
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 23, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
February 11, 2019
CompletedFebruary 18, 2021
September 1, 2018
5 months
October 23, 2015
August 25, 2017
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Satisfied and Very Satisfied With Regimen
Number of subjects satisfied and very satisfied with the three-part treatment regimen
12 weeks
Study Arms (1)
Benzaknen treatment regimen
EXPERIMENTALBenzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
- Proinnovera GmbHcollaborator
Study Sites (1)
EGBERT Mi-Ran
Münster, 48159, Germany
Related Publications (1)
Kim MR, Kerrouche N. Combination of benzoyl peroxide 5% gel with liquid cleanser and moisturizer SPF 30 in acne treatment results in high levels of subject satisfaction, good adherence and favorable tolerability. J Dermatolog Treat. 2018 Feb;29(1):49-54. doi: 10.1080/09546634.2017.1342758. Epub 2017 Jul 5.
PMID: 28678647DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie Leclerc
- Organization
- Galderma R&D
Study Officials
- PRINCIPAL INVESTIGATOR
Mi-Ran EGBERT, MD
Proinnovera GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2015
First Posted
October 28, 2015
Study Start
August 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 18, 2021
Results First Posted
February 11, 2019
Record last verified: 2018-09