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.
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 Type
OBSERVATIONAL
Enrollment
37
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
Skin Research Centre
Toulouse, France
Efficacy of the product on lesions count (Lucky method)
Inflammatory and lesions quantification on the whole face
Time frame: Change from baseline to 8 weeks later, for each group
Efficacy of the product on lesions count (Lucky method)
Inflammatory and lesions quantification on the whole face
Time frame: Change from baseline to 4 weeks later, for each group
Forehead acne lesions count (target area)
Time frame: 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
Clear = 0, Almost clear = 1, Mild = 2, Moderate = 3, Severe = 4
Time frame: Change from 4 weeks to 8 weeks later, for each group, on the target area
Sebum harvest and analysis
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
Time frame: At baseline and after one month of tested product treatment
Comedones lipid harvest and analysis
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
Time frame: At baseline and after one month of tested product treatment
Skin lipids
Measure by FTIR spectroscopy (in vivo non invasive infrared analysis)
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Pilosebaceous follicular ostium size in vivo
Measure by confocal microscope
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Dilated pores on 5-point scale
Absent = 0, Very mild = 1, Mild = 2, Moderate = 3, Severe = 4
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
Patient Global Assessment (PGA) on 6-points scale
Clear worsening = 0, slight worsening = 1, no change = 2, slight improvement = 3, clear improvement = 4, total improvement = 5
Time frame: Change from 4 weeks to 8 weeks later, for each group, on the target area
Self product agreement questionnaire
9-question questionnaire with a majority of scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one
Time frame: At week 8, for tested group
Visible follicles quantification by in vivo visualisation methods
Count by multispectral imaging
Time frame: Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area
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