Clinical trial NCT03832647: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Vichy Laboratoires
Sponsor class: INDUSTRY
First posted: 2019-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 100 subjects per arm
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)
timeFrame: Week 0 (baseline) and Week 12 (final time point)
Secondary outcomes:
measure: Evaluation of the anti-acne efficacy 2 (number of the retentional and inflammatory lesions)
timeFrame: Week 4 and Week 8 (intermediary times point)
measure: Change in the acne stage on face according to the Global Acne Evaluation scale after 4, 8 and 12-week application period
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Change in the residual marks visibility after 4, 8 and 12-week application period
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Change in the pores visibility after 4, 8 and 12-week application period
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Change in the skin shininess after 4, 8 and 12-week application period
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Change in skin greasiness after 4, 8 and 12-week application period
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Change in skin moisturizing after 4, 8 and 12-week application period
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Change in skin ph after 4, 8 and 12-week application period
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Total number of hair follicles per cube at a mean depth of 38 µm after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Diameter of the infundibulum in µm after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Aspect of the border (thickness) (number and percentage) after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Onion like appearence (number and percentage) after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Presence of amorphous material into the infundibulum (number and percentage) after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Signs of inflammation (number and percentage) after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Vascularization (number and percentage) after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Presence of Demodex mites (number and percentage) after a 12-week application period
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Analysis of the efficacy on the skin quality using a questionnaire
timeFrame: Week 12 (final time point)
measure: Analysis of the local tolerance using clinical assessments
timeFrame: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)
measure: Products overall tolerance appreciation by the Dermatologist and the subject
timeFrame: Week 12 (final time point)
measure: Analysis of the cosmetic acceptability using a questionnaire
timeFrame: Week 12 (final time point)
measure: Evaluation of the skin microbiota using sampling (if applicable)
timeFrame: Week 0 (baseline) and Week 12 (final time point)
measure: Analysis of the number of subject with adverse event related to the study product
timeFrame: From Week 0 (baseline) to Week 12 (final time point)
Other outcomes:
Locations:
city: Paris
country: France
facility: INTERTEK
Study officials:
References:
citation: Bouloc A, Roo E, Imko-Walczuk B, Moga A, Chadoutaud B, Dreno B. A skincare combined with combination of adapalene and benzoyl peroxide provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne. J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1727-1731. doi: 10.1111/jdv.14379. Epub 2017 Jul 7.
citation: Muguet Guenot L, Vourc'h Jourdain M, Saint-Jean M, Corvec S, Gaultier A, Khammari A, Le Moigne M, Boisrobert A, Paugam C, Dreno B. Confocal microscopy in adult women with acne. Int J Dermatol. 2018 Mar;57(3):278-283. doi: 10.1111/ijd.13910. Epub 2018 Jan 25.
citation: Gollnick HP, Bettoli V, Lambert J, Araviiskaia E, Binic I, Dessinioti C, Galadari I, Ganceviciene R, Ilter N, Kaegi M, Kemeny L, Lopez-Estebaranz JL, Massa A, Oprica C, Sinclair W, Szepietowski JC, Dreno B. A consensus-based practical and daily guide for the treatment of acne patients. J Eur Acad Dermatol Venereol. 2016 Sep;30(9):1480-90. doi: 10.1111/jdv.13675. Epub 2016 May 14.
citation: Nast A, Dreno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, Finlay AY, Haedersdal M, Lambert J, Layton A, Lomholt HB, Lopez-Estebaranz JL, Ochsendorf F, Oprica C, Rosumeck S, Simonart T, Werner RN, Gollnick H. European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1261-8. doi: 10.1111/jdv.13776. No abstract available.
citation: Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17.