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In this study, we assess the efficacy of a cosmetic product in adults with IV to VI skin phototype.
This study is conducted as a monocentric, controlled, compared with an untreated area and randomized for the area of product application.
To perform this clinical study, minimum 20 - maximum 24 subjects (man or woman), aged from 18 to 50 years are enrolled.
The subjects applied the investigational product on an area located on the anterior side of the forearm, following the laser YAG act, once a day and under occlusion from Day 1 to Day 3 included. Then it is applied twice a day in an open way from Day 4 until Day 18 included.
10 visits are planned:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic product RV2666C LA2984 | Other | The product is applied, according to randomization, on an area located on the anterior side of the forearm, following the laser YAG act, once a day and under occlusion from Day 1 to Day 3 included. Then it is applied twice a day in an open way from Day 4 until Day 18 included. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete wound healing | The wound disappearance is assessed by the investigator by clinical exam of the skin and from standardized photographs taken with a C Cube Caméra©. | Day 1 - Visit 1, Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10. |
| The erythema of the skin | The erythema of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©. | Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10. |
| The pigmentation of the skin | The pigmentation of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©. | Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10. |
| The skin marks | The skin marks are evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10. | Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10. |
| The wound healing quality | The wound healing quality is evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10. |
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Main inclusion criteria :
Main non-inclusion criteria:
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The study is disseminated to the database of potential subjects by email and, if needed, by telephone, describing study title,name(s), address(es) and contacts of the study site(s), name of the Principal Investigator, the parameter(s) in study, study inclusion and exclusion criteria, study objective(s), groups of treatment, namely, if experimental or comparative products are tested, potential risks of adverse events and study duration.
The subjects that manifested interest in participating in the study might be contacted by telephone.
Screening questions are asked in order to screen the main inclusion and exclusion criteria Subjects' answers to the telephonic recruitment are evaluated by the Principal Investigator who decides if the subject is to be selected for the recruitment visit.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Research Center | Toulouse | France | 31000 | France |
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| Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10. |
| The global efficacy of the product | The global efficacy of the product is assessed by the subject with a 7-questions questionnaire. | Day 19 - Visit 10 |
| The transepidermal water loss | The transepidermal water loss is measured by a clinical research technician using a Vapometer©. | Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10. |
| Standardized photographs in an illustrative purpose | Photographs in 2D and 3D are taken using a C Cube Camera©. | Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10. |