NCT04301063

Assess the Effects and the Tolerance of Cosmetic Product in the Follow-up Phase of Facial Acne for 1 Year

An International Multicentric Open-label Descriptive Study to Assess the Effects and Evaluate the Tolerance of the Cosmetic Care Product RV3278A in the Follow-up Phase of Facial Acne in Teenagers and Young Adults for 1 Year

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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 called oil glands) that make sebum, an oil that moistens your hair and skin. Most of the time, the glands make the right amount of sebum and the pores are fine. But sometimes a pore gets clogged up with too much sebum, dead skin cells, and germs called bacteria. This can cause acne. Pierre Fabre Laboratories have developed a cosmetic care product, a cream which is commercialized since September 2019. This leave-on skin care product is adapted for acne-prone skin. In this study, we are interested in the effects of this care product in facial acne evolution for 12 months (quality of life, acne severity, number of acne flares). Also, we are interested in the subject's satisfaction regarding the use of this care product. This study will also enable to know if the product is well tolerated in such application circumstances. This clinical study will be carried out in 54 subjects (female or male), aged between 12 and 35 years, in about 10 centers in different European countries. The maximal duration of the study for a subject will be 1 year. If you give your consent to take part in this study, you will receive a cosmetic care product, also called study product, that you will apply on your face twice a day (morning and evening) for the whole duration of the study. What makes this study original is the use of a smartphone application to help you to comply with the study procedures and to help the investigator to follow you.

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: increase of sebum production, follicular hyperproliferation and hyperkeratinisation leading to comedones formation, inflammation and proliferation of the bacteria Propionibacterium acnes.1,2 Acne affects nearly all people between the ages of 15 and 17 years and in 15 to 20% of young people, acne is moderate to severe. The prevalence of acne in 12-24 years is 85%. 3 The presence of acne may have psychologic or emotional impact: it may negatively affect mood, quality of life and self-esteem in adolescents and adults and can increase the risk of anxiety, depression and suicidal ideation2,3. There is not always a correlation between the acne clinical severity and the quality of life. According to its severity, the acne vulgaris can be treated locally with topical agents used alone or in combination, such as benzoyl peroxide, retinoids (adapalene…), antibiotics, azelaic acid, etc. Oral treatments are usually taken for more severe acne and include antibiotics, contraceptives and isotretinoin. They also can be used in combination with local treatments.1,4 The product RV3278A is a non-rinsed cosmetic cream intended to be used every day on adolescents and young adults with acne-prone skin. In accordance with the Pierre Fabre laboratories safety charter, a full program of tolerance has been performed including pre-clinical and clinical studies in healthy volunteers. The product presents a sufficient safety level to be used for this protocol. The use of cosmetics in acne is well established. The goals of cosmetics in acne are * to complement drug therapy, by alleviating their side effects and thereby improving treatment adherence. * to contribute to improving the status of the clinically non-lesional skin. Clinically non-lesional skin in acne patients (CNLSAP) is well known for its greasiness, which is due to overproduction of sebum. Another important character of the CNLSAP is the "invisible microcomedone" (IMC). 1. IMC can be visualized by "stripping-it-out" with cyanoacrylate. 2. IMC is composed as a mixture of cellular components of the follicular infundibulum, and sebum lipids, both of which can be analysed ex-vivo by all tools of currently available technology. 3. IMC is considered to be the root of any subsequent clinical lesion, both non- inflammatory ones (open and close comedones microcysts) and inflammatory ones (papules pustules etc..)5 4. The number/cm2 and size of the IMC are highly variable and correlate with subsequent acne severity. 5. Therefore, any cosmetic product able to modify the number/cm2 and size of the IMC would contribute to maintain healthier skin in acne patients and reduce the use of drug therapy. A pilot study in acne patients has shown that an herbal extract used topically for several weeks months was able to reach such goals. The present study is aimed at reproducing these results in several dermatology practices in Europe.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
OTHER	RV3278A	RV3278A is a non-rinsed cosmetic cream intended to be used every day on adolescents and young adults with acne-prone skin.

Timeline

• Start date: 2019-02-04
• Primary completion: 2020-05-06
• Completion: 2020-05-06
• First posted: 2020-03-09
• Last updated: 2021-04-02

Locations

8 sites across 3 countries: France, Italy, Poland