Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin

Last updated: April 29, 2021
Sponsor: Pierre Fabre Dermo Cosmetique
Overall Status: Completed

Phase

N/A

Condition

Acne

Rash

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT04873089
RV3278A2018243
  • Ages 18-35
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to evaluate, at different times, the RV3278A - ET0943 cosmetic product efficacy after 8 weeks of application on the face (twice-daily application). At T1 (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed:

  • The reduction of the pilosebaceous follicular ostium size in vivo (pores) on the forehead

  • The clinical evaluation (count of non inflammatory and inflammatory acne lesions, IGA score) of the face

  • The reduction in visible follicles

  • The standardized numerical photographs of face and ¾ right and left profile in normal, parallel polarized, cross polarized and UV light

  • The analysis of the skin lipids of the forehead

  • The qualitative and quantitative analysis of the sebum and comedones constituents (nose wings)

This is a comparative, open-labelled study, on subjects with oily and acne prone skins on the face.

Each group includes 18 subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Criteria related to the population:
  • Male or Female aged between 18 and 35 years included
  • Subject with phototype I to IV included
  • Subject having signed his/her written informed consent for his/her participationin the study
  • Subject who is currently not participating in another clinical study
  • Subject affiliated to a social security system or health insurance, or is abeneficiary
  • For woman of childbearing potential: use of an effective method of contraceptionand using it during the whole duration of the study
  1. Criteria related to diseases and general health:
  • Subject with oily, blemished skin and dilated pores on the face including openand closed comedones of the retention type (on the forehead, temporal areas andnose wings) and some inflammatory lesions:
  • Retention aspect: microcomedones and open comedones count on the forehead (>
  • Inflammatory aspect: lesions ≤ 10 count on the whole face

Exclusion

Exclusion Criteria:

  1. Criteria related to the population:
  • For woman of childbearing potential: subject pregnant or breastfeeding orplanning to be pregnant during the study
  • Subject having already known allergy to latex
  • Subject having already known allergy to the test product or associated productcomponents
  • Subject having scar(s) or other skin characteristic on the study areas (forehead,temporal areas and nose wings) and which, size is not compatible with the studyrealization
  • Subject who, has planned to apply exfoliating, keratolytic and/or self-tanningproducts on the face within 2 weeks prior to inclusion.
  • Subject who, has planned to be exposed to the natural or artificial UV during thestudy
  • Subject who is not likely to be compliant with study-related requirements
  • Subject deprived of freedom by administrative or legal decision or underguardianship
  1. Criteria related to diseases and general health:
  • Inflammatory or immunological dermatosis (atopic dermatitis, psoriasis, severeinflammatory acne, cutaneous seborrhoeic dermatitis, vitiligo of the face..) of theface, or other dermatological face illness in progress at the time of inclusion on thesample areas (pigmentation of the sample areas by melasma, solar erythema orartificial post UV...)
  1. Criteria related to treatments
  • Facial treatments :
  • Any topical anti-acne antibiotics (topical Erythromycin or topical Dalacin)applied during more than 5 consecutive days within 4 weeks before theinclusion
  • Any topical treatment (dermo corticoids, retinoids, antibiotics,antifungals…) ongoing or applied within 4 weeks before the inclusion
  • Oral intake of antibiotic, zinc gluconate or hormonal anti-acne treatments,ongoing or taken during more than 5 consecutive days within the month before theinclusion
  • Oral intake of isotretinoin within 6 months before the inclusion
  • Anti-inflammatory treatments (steroids or no steroids) according to theinvestigator's assessment
  • Hormonal contraception established or modified within 3 months before theinclusion
  • Application of skin care product containing exfoliating, keratolytic orself-tanning ingredients applied on the face within 15 days before the inclusion
  • Oral treatment (cardiovascular, endocrinal, rheumatological, urogenital,neuropsychiatric, immunosuppressant) established within 2 months before theinclusion not stabilized
  • Hygiene, skin care or make-up habits modified within less than one month beforethe inclusion

Study Design

Total Participants: 37
Study Start date:
September 17, 2018
Estimated Completion Date:
December 21, 2018

Study Description

This study is monocentric, comparative versus non-treated group, open-labelled, exploratory, conducted in adults having oily and acne prone skin.

The study includes 4 visits for each group, including subjects' selection:

  • V0: Subjects' selection

  • V1: Baseline inclusion

  • V2: 4 weeks, follow-up visit

  • V3: 8 weeks, study end

The maximal study duration is 61 days. The front, temporal areas and nose wings are defined as the study interest areas for superficial samples.

The evaluation is at 3 times: T1 baseline, T2 at 4 weeks and T3 at 8 weeks of application of RV3278A formula ET0943 with comparison of each time versus baseline.

There are twice-daily applications (morning and evening) of the test product on the face.

Connect with a study center

  • Skin Research Centre

    Toulouse, 31300
    France

    Site Not Available

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