Status:
COMPLETED
Assess the Effects and the Tolerance of Cosmetic Product in the Follow-up Phase of Facial Acne for 1 Year
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18-35 years
Brief Summary
Acne is a chronic inflammatory disease of the pilo-sebaceous unit in the skin. Indeed, your skin is covered with tiny holes called hair follicles, or pores. These pores contain sebaceous glands (also ...
Detailed Description
Acne vulgaris is one of the most common skin conditions in teenagers that often persists into adulthood. It is a chronic inflammatory disease of the pilosebaceous unit resulting from four main factors...
Eligibility Criteria
Inclusion
- Criteria related to the population:
- Female or male aged between 12 and 35 years included
- Phototype I, II, III or IV according to Fitzpatrick classification
- For major subject:
- o Subject who has signed his/her written informed consent for his/her participation in the study
- For minor subject:
- o Subject and/or parent(s)/legal representative(s), according to national regulations, who have signed his/her written informed consent for subject's participation in the study
- If required by national regulations, subject must be registered with health social security or health social insurance
- Woman of childbearing potential:
- o use of an effective contraceptive method, as assessed by the investigator, for at least 3 months before the inclusion, accepting to go on using this method during the whole duration of the study
- Subject or parent (s) / guardian(s) owning a smartphone with adequate parameters to download the application (including having enough storage space, a version of android or iOS compatible with the application) and a web access
- Related to the diseases and skin condition:
- Subject with oily skin
- Subject with dilated pores on the forehead
- Almost clear, mild or moderate facial acne with score index severity GEA=1 (almost clear), GEA=2 (mild) or GEA=3 (moderate) assessed on a scale ranged from 0 to 5.
Exclusion
- Related to the population:
- Subject who is unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/ her consent to participate
- Subject who is currently participating, plans to participate or has participated in another clinical study prior to inclusion visit, liable to interfere with the study assessments according to the investigator
- For woman of childbearing potential: subject pregnant or breastfeeding or planning to be pregnant during the study
- Subject deprived of freedom by administrative or legal decision or under guardianship
- Subject who, in the judgement of the investigator, is not likely to be compliant with study-related requirements
- Subject who is a family member of the investigator or any associate, colleague, employee assisting in the conduct of the study ( secretary, nurse, technician…)
- Related to the disease:
- Severe type of acne (Acne conglobata, Acne fulminans or nodulocystic acne) or acneiform induced eruptions according to investigator's assessment
- Facial skin pathology other than acne, skin abnormalities or dermatological condition on the face liable to interfere with the study assessments (including psoriasis, atopic dermatitis, skin infectious disease of viral, bacterial, fungus or parasitic origin …)
- Forehead scars in tested area liable to interfere with samples realisation (cyanoacrylate stripping)
- Acute, chronic or progressive disease or medical history considered by the investigator hazardous for the subject or incompatible with the study or liable to interfere with the study assessments
- Clinical signs of hormonal dysfunctions or hyperandrogenism
- History of allergy or intolerance to any cosmetic product, to the investigational product ingredients or to cyanoacrylate
- Solar erythema on the face due to excessive UV exposure
- Related to the treatments/products:
- Any surgery, chemical or physical treatment on the experimental area done within 6 months before the inclusion or planned during the study
- Oral intake of isotretinoin within 6 months before the inclusion
- Hormonal contraception or hormonal antic-acne treatment established or modified within 3 months before the inclusion or planned to be established or modified during the study
- Any oral or topical anti-acne treatment taken/applied on the face within 1 month before the inclusion
- Use of topical or systemic treatment during the previous weeks or ongoing, liable to interfere with the assessment of the cutaneous tolerance and effects of the studied product (according to the investigator's appreciation)
- Facial cleansing or skin care product containing anti-acne or keratolytic ingredients applied within 15 days before the inclusion or planned to be applied during the study
- Facial cleansing or skin care product (including moisturizer, make-up remover, foundation cream/powder) established or modified within 15 days before the inclusion
- Any rinsed/non-rinsed skin care product (including moisturizer and sunscreen), make-up (including foundation cream/powder) or make-up remover applied on the face (including eyes and mouth) the day of the inclusion visit
Key Trial Info
Start Date :
February 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04301063
Start Date
February 4 2019
End Date
May 6 2020
Last Update
April 2 2021
Active Locations (8)
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1
Centre de Santé Sabouraud - Hôpital Saint Louis
Paris, France, 75010
2
cabinet Médical
Sèvres, France, 92310
3
Skin Research Centre
Toulouse, France, 31300
4
Medical Office
Milan, Italy, 20124