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

Sponsor

Pierre Fabre Dermo Cosmetique (Industry)

Overall Status

Completed

CT.gov ID

NCT04873089

Collaborator

(none)

Enrollment

Location

3.1

Actual Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne	Other: Cosmetic product

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

37 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

RV3278AET0943 Cosmetic Product Efficacy Applied for 8 Weeks in Adults Having Oily and Acne Prone Skin: Comparative Study Versus Not Treated Group

Actual Study Start Date :

Sep 17, 2018

Actual Primary Completion Date :

Dec 21, 2018

Actual Study Completion Date :

Dec 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
RV3278A arm RV3278A study product is applied twice a day (morning and evening) on the face during the whole study.	Other: Cosmetic product 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
Control Group Subjects included in the control group did not receive the test product or other associated product

Arm

Intervention/Treatment

RV3278A arm

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

Other: Cosmetic product

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

Control Group

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

Outcome Measures

Primary Outcome Measures

Efficacy of the product on lesions count (Lucky method) [Change from baseline to 8 weeks later, for each group]
Inflammatory and lesions quantification on the whole face

Secondary Outcome Measures

Efficacy of the product on lesions count (Lucky method) [Change from baseline to 4 weeks later, for each group]
Inflammatory and lesions quantification on the whole face
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]
Clear = 0, Almost clear = 1, Mild = 2, Moderate = 3, Severe = 4
Sebum harvest and analysis [At baseline and after one month of tested product treatment]
Quantification of free fatty acid (FFA) / triglyceride (TG) ratio by infrared spectroscopy: Forehead sebum was collected on absorbent paper then the lipid composition was analysed by infrared spectroscopy to determine the free fatty acids to triglycerides ratio
Comedones lipid harvest and analysis [At baseline and after one month of tested product treatment]
Quantification of free fatty acid / triglyceride ratio by GC/MS: Samples were collected with patch on nose wings. Comedones were collected and lipids extracted according to the Bligh & Dyer (Bligh and Dyer, 1959). The biochemical exploration was performed by the screening of neutral lipids on GC/MS
Skin lipids [Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area]
Measure by FTIR spectroscopy (in vivo non invasive infrared analysis)
Pilosebaceous follicular ostium size in vivo [Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area]
Measure by confocal microscope
Dilated pores on 5-point scale [Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area]
Absent = 0, Very mild = 1, Mild = 2, Moderate = 3, Severe = 4
Patient Global Assessment (PGA) on 6-points scale [Change from 4 weeks to 8 weeks later, for each group, on the target area]
Clear worsening = 0, slight worsening = 1, no change = 2, slight improvement = 3, clear improvement = 4, total improvement = 5
Self product agreement questionnaire [At week 8, for tested group]
9-question questionnaire with a majority of scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one
Visible follicles quantification by in vivo visualisation methods [Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area]
Count by multispectral imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 (>

Inflammatory aspect: lesions ≤ 10 count on the whole face

Exclusion Criteria:

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 apply exfoliating, keratolytic and/or self-tanning products on the face within 2 weeks prior to inclusion.
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:

Inflammatory or immunological dermatosis (atopic dermatitis, psoriasis, severe inflammatory acne, cutaneous seborrhoeic dermatitis, vitiligo of the face..) of the face, or other dermatological face illness in progress at the time of inclusion on the sample areas (pigmentation of the sample areas by melasma, solar erythema or artificial post UV...)

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 the inclusion
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 the inclusion
Oral intake of isotretinoin within 6 months before the inclusion
Anti-inflammatory treatments (steroids or no steroids) according to the investigator's assessment
Hormonal contraception established or modified within 3 months before the inclusion
Application of skin care product containing exfoliating, keratolytic or self-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 the inclusion not stabilized
Hygiene, skin care or make-up habits modified within less than one month before the inclusion