Status:
COMPLETED
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
Lead Sponsor:
Vichy Laboratoires
Conditions:
Acne
Eligibility:
All Genders
16-35 years
Phase:
PHASE4
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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
- Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 2 weeks prior to study inclusion
- Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion
- Subjects who have applied cosmetic products for more than 5 consecutive days with alpha hydroxyl-acids, vitamin C, hyaluronic acids in the 1 week prior the study inclusion
- Subjects having washed the face and/or the hair the day of the study inclusion (only water is accepted the morning of the study inclusion)
- Subjects having applied any topical products on face (including make-up) the day of the study inclusion
- Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
- Subjects who declare to be deprived of their freedom by administrative or legal decision or who are under guardianship
- Subjects who cannot be contacted by telephone in case of emergency
- Subjects belonging to the staff of the study centre
- Subjects in an exclusion period or participating in another biomedical research study
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03832647
Start Date
February 18 2019
End Date
February 17 2020
Last Update
October 18 2021
Active Locations (1)
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1
INTERTEK
Paris, France, 75013