Clinical TrialID 6922

Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne

NCT03832647

Acne

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
6922
Evidence Id
6922
Core Evidence Id
6922
Source Clinical Trial Id
6914
Herb2 Clinical Trial Id
HBCT006914
Nct Id
NCT03832647
Title
Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne
Status
Completed
Phase
Phase 4
Study Result
No
Study Condition
Acne
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
COMBINATION_PRODUCT: Epiduo|DRUG: Salicylic Acid|OTHER: Hydréane légère
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Child, Adult
Enrollment
200
Outcome Measure
Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions), Change in the number of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) on face after a 12-week application period At Week 0 (before any application) and Week 12 (after a 12-week application period), a counting of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) will be performed by a Dermatologist. The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin)., Week 0 (baseline) and Week 12 (final time point)
Sponsor Collaborator
Vichy Laboratoires
Funded By
INDUSTRY
Location
INTERTEK, Paris, 75013, France
Other Id
VCA 18-01|2018-A02481-54
Start Date
2019-02-18
Primary Completion Date
2020-02-17
Completion Date
2020-02-17
First Posted
2019-02-06
Results First Posted
Last Update Posted
2021-10-18
Study Document
Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/47/NCT03832647/Prot_SAP_000.pdf
Study Url
https://clinicaltrials.gov/study/NCT03832647
Title Cn
Title En
Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne
Bilingual Status
semi_complete