Clinical Trials/NCT03832647

NCT03832647

Completed

Phase 4

Multicentric, Parallel, Randomized, Double Blind Study Under Dermatological Control to Evaluate the Anti-acne Efficacy of a Dermo-cosmetic Product (Fla 688977 33) Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer (Hydréane légère, Cosmétique Active International) During a 12-week Application Period in Male and Female Subjects Presenting With Mild to Moderate Acne

Vichy Laboratoires1 site in 1 country200 target enrollmentFebruary 18, 2019

ConditionsAcne

InterventionsEpiduo Salicylic Acid Hydréane légère

DrugsSalicylic Acid

Overview

Phase: Phase 4
Intervention: Epiduo
Conditions: Acne
Sponsor: Vichy Laboratoires
Enrollment: 200
Locations: 1
Primary Endpoint: Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment

Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm), Intra-subject & inter subject comparisons

Registry

clinicaltrials.gov

Start Date

February 18, 2019

End Date

February 17, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vichy Laboratoires

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and/or female subjects aged 16 to 35 years
•Subjects presenting with mild to moderate acne (stage 2 or stage 3 with at least 12 inflammatory lesions on face according to the Global Acne Evaluation)
•Female subjects of child-bearing potential who:
•use the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, cervical cap, vaginal ring and injection) for at least 3 months prior to study inclusion and throughout the study or
•use a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap and spermicide) for at least 1 month prior to study inclusion and throughout the study or
•have no sexual intercourse and agreeing not to have any throughout the study or
•are surgically sterile (oophorectomy, hysterectomy or tubal ligation),
•Subjects and/or all legal representatives (for minor subjects) who have given written informed consent
•Subjects who are willing to comply with the study requirements
•Subjects with Social Security (health insurance) coverage (according to the French requirements)

Exclusion Criteria

•Subjects with any systemic disorder or face dermatoses other than acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
•Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
•Subjects with a history of skin cancer
•Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study
•Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid ...) in the 3 months prior the study inclusion
•Subjects with hypersensitivity to the active substances of Epiduo (Adapalene and/or benzoyl peroxide) or to one of its excipients
•Subjects who are sensitive to peroxides (oxygenated water)
•Subjects who have received isotretinoin treatment in the 6 months prior to study inclusion
•Subjects who have been exposed to excessive UV light (natural or artificial) in the 1 month prior to the study inclusion or having planned excessive UV light exposure during the study (e.g. ski holidays, holidays in the tropics...)
•Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion

Arms & Interventions

Salicylic acid & Epiduo 0.1%-2.5% Topical Gel

Salicylic acid: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.

Intervention: Epiduo

Salicylic acid & Epiduo 0.1%-2.5% Topical Gel

Salicylic acid: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.

Intervention: Salicylic Acid

Hydréane légère & Epiduo 0.1%-2.5% Topical Gel

Hydréane légère: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.

Intervention: Epiduo

Hydréane légère & Epiduo 0.1%-2.5% Topical Gel

Hydréane légère: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.

Intervention: Hydréane légère

Outcomes

Primary Outcomes

Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)

Time Frame: Week 0 (baseline) and Week 12 (final time point)

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).

Secondary Outcomes

Evaluation of the anti-acne efficacy 2 (number of the retentional and inflammatory lesions)(Week 4 and Week 8 (intermediary times point))
Change in the pores visibility after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Change in skin greasiness after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Change in the residual marks visibility after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Change in skin ph after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Analysis of the efficacy on the skin quality using a questionnaire(Week 12 (final time point))
Change in skin moisturizing after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Diameter of the infundibulum in µm after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Change in the acne stage on face according to the Global Acne Evaluation scale after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Change in the skin shininess after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Signs of inflammation (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Vascularization (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Analysis of the number of subject with adverse event related to the study product(From Week 0 (baseline) to Week 12 (final time point))
Total number of hair follicles per cube at a mean depth of 38 µm after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Presence of Demodex mites (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Analysis of the local tolerance using clinical assessments(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
Products overall tolerance appreciation by the Dermatologist and the subject(Week 12 (final time point))
Presence of amorphous material into the infundibulum (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Analysis of the cosmetic acceptability using a questionnaire(Week 12 (final time point))
Aspect of the border (thickness) (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Onion like appearence (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
Evaluation of the skin microbiota using sampling (if applicable)(Week 0 (baseline) and Week 12 (final time point))