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

NCT04873089 | Completed

• 1 other identifier: RV3278A2018243
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne

Keywords

Lipids; Biometrological; Microcomedomes; Sebum; Fatty acids; Phytotherapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of the product on lesions count (Lucky method)

  Inflammatory and lesions quantification on the whole face

  Change from baseline to 8 weeks later, for each group

Secondary Outcomes (11)

• Efficacy of the product on lesions count (Lucky method)

  Change from baseline to 4 weeks later, for each group

• Forehead acne lesions count (target area)

  Change from baseline to 4 weeks and 8 weeks later for each group, on the target area

• Investigator Global Assessment (IGA) on 5-point scale

  Change from 4 weeks to 8 weeks later, for each group, on the target area

• Sebum harvest and analysis

  At baseline and after one month of tested product treatment

• Comedones lipid harvest and analysis

  At baseline and after one month of tested product treatment

Study Arms (2)

RV3278A arm

RV3278A study product is applied twice a day (morning and evening) on the face during the whole study.

Other: Cosmetic product

Control Group

Subjects included in the control group did not receive the test product or other associated product

Interventions

Cosmetic product OTHER

It is a comparative study with two parallel groups of subjects: * Tested group: twice daily application of the cream RV3278A cosmetic product on the whole face * Comparative group: no application of study product or reference product

RV3278A arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects have been recruited from the panel of the centre. An investigator made a dermatological examination of the subjects before inscription in the panel. Data from this clinical examination, stored in the computer database with the consent of the subjects, can ensure the recruitment; computer software being questioned based on the eligibility criteria of the study.

You may qualify if:

• 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 participation in the study
• Subject who is currently not participating in another clinical study
• Subject affiliated to a social security system or health insurance, or is a beneficiary
• For woman of childbearing potential: use of an effective method of contraception and using it during the whole duration of the study
• Criteria related to diseases and general health:
• Subject with oily, blemished skin and dilated pores on the face including open and closed comedones of the retention type (on the forehead, temporal areas and nose wings) and some inflammatory lesions:
• Retention aspect: microcomedones and open comedones count on the forehead (\> 10)
• Inflammatory aspect: lesions ≤ 10 count on the whole face

You may not qualify if:

• Criteria related to the population:
• For woman of childbearing potential: subject pregnant or breastfeeding or planning to be pregnant during the study
• Subject having already known allergy to latex
• Subject having already known allergy to the test product or associated product components
• 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 study realization
• Subject who, has planned to be exposed to the natural or artificial UV during the study
• Subject who is not likely to be compliant with study-related requirements
• Subject deprived of freedom by administrative or legal decision or under guardianship
• Criteria related to diseases and general health:
• Criteria related to treatments
• Facial treatments :
• Anti-inflammatory treatments (steroids or no steroids) according to the investigator's assessment

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Centre

Toulouse, 31300, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sebum and comedones constituents

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Cosmetics

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Thérèse NOCERA, MD dermatologist

  SKIN RESEARCH CENTRE - Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 5, 2021
• Study Start: September 17, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)