Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||16 Years - 35 Years|
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.
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: 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.
Placebo Comparator: 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.
Combination Product: - Epiduo
100 per arm Adapalene/ Benzoyl Peroxide
Drug: - Salicylic Acid
Other: - Hydréane légère
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.