Assess the Effects and the Tolerance of Cosmetic Product in the Follow-up Phase of Facial Acne for 1 Year
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Observational

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.
    

Intervention name(s): RV3278A
Intervention type(s): Other
Intervention description(s): RV3278A is a non-rinsed cosmetic cream intended to be used every day on adolescents and young adults with acne-prone skin.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects will be enrolled from the investigator's outpatients' reception. Subjects
        corresponding to eligibility criteria will be contacted by the investigator who will
        propose them to take part in the clinical study.
      
Biospecimen description: 
      Cyanoacrylate skin surface stripping (CSSS) of the stratum corneum