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Lack of recruitment
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This exploratory study aims to evaluate the effects of the test product RV5026B - ET1732 on erythema, as well as on the sensations of discomfort and relief perceived in subjects with erythrocouperose and associated pityriasis folliculorum.
We wish to evaluate:
The test product RV5026B - ET1732 was developed to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group (first hemiface) | Experimental | Treated group = hemi-face with the reference topical product and the tested product RV5026B - ET1732 during period 2 | |
| Control group (second hemiface) | Other | Control group = hemi-face with the reference topical product alone during period 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV5026B - ET1732 - Period 1 | Other | Period 1 (1 month): The tested product RV5026B - ET1732 will be applied twice a-day on full-face The product sould be applied in sufficient quantity to cover the application area. |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema score | Assessed by the investigator according to the Investigator Global Assessment - IGA - scale (score from 0 to 3: None toSevere) on each side of the face | Day 1, Day 29 & Day 57 |
| Overall dynamic efficiency score | Assessed by the investigator according to Investigator's Global Assessment (IGA) - (-3 to +3) (Very significant worsening = -3to Very significant improvement = +3) compared with baseline status at visit 1 on each side of the face | Day 29 & Day 57 |
| Demodex density | assessed by Standardized Skin Surface Biopsy (SSSB1 & SSSB2 and SSSB1+2) on each hemiface by on-site optical microscope count, then protein analysis on SSSBs sample | Day 1, Day 29 & Day 57 |
| Rating of the intensity of the erythema | (score from 0 to 100) by centralized a posteriori analysis of the photographs taken on each side of the face, carried out by an expert dermatologist using software presenting the images taken for each of the subjects, blindly | Day 1, Day 29 & Day 57 |
| Flush score | Score over the last 3 days preceding the assessment according to the Global Flushing Severity Score - GFSS - numerical scale (score from 0 to 10 - None to Extreme: ) on each side of the face | Day 1, Day 29 & Day 57 |
| Dynamic SGA (subject global assessment) scale | Scale with 7 points (-3 to +3) (Very significant worsening = -3 to Very significant improvement = +3) in comparison with the initial state of visit 1 on each side |
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Main inclusion criteria:
Main non-inclusion criteria:
- Subject presenting, on the day of inclusion, a dermatological condition of the face other than that studied
ORAL/GENERAL TREATMENTS that were planned to be taken during the study OR that were taken:
A. In the last 3 months:
- Any change in hormone replacement therapy.
- Any oral treatment Vit A or derivatives
B. In the last 4 weeks:
- Any change in oral drug treatment that could modify the skin characteristics of the subjects and interfere with the performance of the study product
- Tetracyclines
- Immunosuppressant
- Antiparasitic
- Corticosteroid or NSAID taken for more than 5 consecutive days
C. In the last 2 weeks:
- Antibiotic with known cutaneous impact
LOCAL TREATMENTS that were planned to be taken during the study OR that were taken:
A. In the last 3 months:
- Vascular laser of the face
B. In the last 4 weeks:
- Any topical medicinal product on the face that could modify the skin characteristics of the subjects and interfere with the performance of the study product.
C. In the last 10 days:
- Changes to any topical cosmetic product (toiletries, care products and makeup) on the face
D. In the last 7 days:
E. Since the last wash performed the night before:
- Application of topical treatment, rinsed or non-rinsed dermocosmetic product on the face
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr FORTON | Schaarbeek | 1030 | Belgium |
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During the first period, the tested product will be applied to the entire face.
At Visit 2, after investigator assessments, the subjects will stop the study if they don't need a treatment by reference topical product. If they need it, they will continue the study and will apply:
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| reference topical product - Period 2 | Drug | Period 2 (1 month) : the reference topical product, prescribed by the investigator will applied each evening on the whole face. |
| RV5026B - ET1732 - Period 2 | Other | Period 2 (1 month) : The tested product RV5026B - ET1732 will be applied twice a-day on randomised half-face. The evening application will be done 15 minutes after the application of the reference treatment. Hands must be washed between the application of the 2 products. |
| Day 1, Day 29 & Day 57 |
| Subject acceptability questionnaire | assessed by the subject with subject's questionnaire | Day 29 & Day 57 |
| Tolerance of the products for 2 months of use by adverse events | Recording of Adverse events | Day 1, Day 29 & Day 57 |
| Tolerance of the tested product for 2 months of use by global tolerance per subject | assessed by the investigator for both groups and per subject, considering all individual AE and their characteristics, based on a 5-point scale (0=Bad tolerance, 4= Excellent tolerance) | Day 29 & Day 57 |
| Subject's compliance regarding the test product | The subject will report his compliance in a subject's diary. | During the entire course of the study (approximately 57 days) |