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

Vichy Laboratoires

Status and phase: Completed; Phase 4

Conditions: Acne

Treatments: Drug: Salicylic Acid; Combination Product: Epiduo; Other: Hydréane légère

Study type: Interventional

Funder types: Industry

Identifiers

NCT03832647

2018-A02481-54 (Other Identifier)

VCA 18-01

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and/or female subjects aged 16 to 35 years

2. 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)

3. 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),

4. Subjects and/or all legal representatives (for minor subjects) who have given written informed consent

5. Subjects who are willing to comply with the study requirements

6. Subjects with Social Security (health insurance) coverage (according to the French requirements)

Exclusion criteria

1. 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)
2. 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
3. Subjects with a history of skin cancer
4. Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study
5. Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid ...) in the 3 months prior the study inclusion
6. Subjects with hypersensitivity to the active substances of Epiduo (Adapalene and/or benzoyl peroxide) or to one of its excipients
7. Subjects who are sensitive to peroxides (oxygenated water)
8. Subjects who have received isotretinoin treatment in the 6 months prior to study inclusion
9. 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...)
10. 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
11. 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
12. 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
13. 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
14. 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)
15. Subjects having applied any topical products on face (including make-up) the day of the study inclusion
16. 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
17. Subjects who declare to be deprived of their freedom by administrative or legal decision or who are under guardianship
18. Subjects who cannot be contacted by telephone in case of emergency
19. Subjects belonging to the staff of the study centre
20. Subjects in an exclusion period or participating in another biomedical research study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Salicylic acid & Epiduo 0.1%-2.5% Topical Gel

Experimental group

Description:

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

Treatment:

Drug: Salicylic Acid

Combination Product: Epiduo

Hydréane légère & Epiduo 0.1%-2.5% Topical Gel

Placebo Comparator group

Description:

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

Treatment:

Combination Product: Epiduo

Other: Hydréane légère