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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV3278A arm | RV3278A study product is applied twice a day (morning and evening) on the face during the whole study. |
| |
| Control Group | Subjects included in the control group did not receive the test product or other associated product |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic product | Other | It is a comparative study with two parallel groups of subjects:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the product on lesions count (Lucky method) | Inflammatory and lesions quantification on the whole face | Change from baseline to 4 weeks later, for each group |
| Forehead acne lesions count (target area) |
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Inclusion Criteria:
Criteria related to the population:
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:
Exclusion Criteria:
Criteria related to the population:
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 :
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
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Thérèse NOCERA, MD dermatologist | SKIN RESEARCH CENTRE - Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Research Centre | Toulouse | 31300 | France |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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Sebum and comedones constituents
| 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 | 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 | 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 | At baseline and after one month of tested product treatment |
| Skin lipids | Measure by FTIR spectroscopy (in vivo non invasive infrared analysis) | 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 | 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 | 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 | 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 | At week 8, for tested group |
| Visible follicles quantification by in vivo visualisation methods | Count by multispectral imaging | Change from baseline to 4 weeks and 8 weeks later, for each group, on the target area |