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Acne vulgaris (acne) is a chronic inflammatory pathology of the pilosebaceous unit. Its prevalence is about 85% of teenagers and is constantly increasing in adults, especially women. Acne is a multifactorial disease involving abnormalities in follicular keratinization, sebum production, skin microbiota and inflammation.
The early stage of acne is characterized by the presence of primary retentional lesions: the open comedones (or blackheads) and closed comedones (or whitehead). These retentional lesions can progress to highly inflammatory lesions: superficial inflammatory lesions (papules and pustules) and in some cases in deep inflammatory lesions (nodules). Finally, acne lesions can lead to the development of superficial post inflammatory erythema or hyperpigmentation, resulting in emotional distress and a poorer quality of life.
Currently, a better understanding of the switch from healthy to acne-prone skin, but also of the transition from retentional lesions to more severe inflammatory lesions, seems essential to propose adapted and specific treatments.
The aim of this study is to better understand acne pathophysiology of the face by a multi-omic approaches, biometrological analysis and consumer needs collection to bring information, in the same study on the local ecosystem of non-lesional areas, retentional lesional areas and inflammatory lesional areas of adult acne prone skin, compared to acne free face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control subject group | Other |
| |
| Subject group with mild to moderate acne on the face | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biometrological measurements | Other | Measurements will be taken from the face:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous pH measurement | by pH - pHmeter | baseline (Visit 1- Day 1) |
| Sebum quantification | by Lipidic Index (LI) - Sebumeter® | baseline (Visit 1- Day 1) |
| Cutaneous barrier integrity | by Trans-Epidermal Water Loss (TEWL) - Aquaflux® | baseline (Visit 1- Day 1) |
| Epigenetic analysis by sampling method (urine) | baseline (Visit 1- Day 1) | |
| Microbiota profile by sampling method (swabs) | By non-targeting metagenomics | baseline (Visit 1- Day 1) |
| Microbiota profile by sampling method (extracted comedones) | for acne group only | baseline (Visit 1- Day 1) |
| Metabolomic profile by sampling method (swabs) | By metabolomic analysis | baseline (Visit 1- Day 1) |
| Metabolomic profile by sampling method (extracted comedones) | for acne group only | baseline (Visit 1- Day 1) |
| Lipidomic profile by mass spectroscopy (in-vivo measurements) |
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Inlcusion criteria:
Criteria related to the population:
Criteria related to diseases:
Specific for acne group:
• Subject with acne lesions on the face, with a Global Acne Evaluation (GEA) score evaluated on the face of 2 (mild) or 3 (moderate) assessed by the investigator on a 5-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe)
Non-inclusion criteria:
Criteria related to the population:
Criteria related to the disease:
Criteria related to skin condition:
• Subject having any other dermatologic condition than acne, or characteristics (like tattoo) on the face liable to interfere with the study assessments
Specific for control group:
Criteria related to treatments and/or products:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Research Center | Toulouse | 31000 | 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 |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Biological sampling | Other | Samples will be taken from the face:
|
|
| Clinical assessments | Other | Only for acne group: acne scores will be evaluated on the face by the investigator |
|
| Questionnaire | Other | Only for acne group: consumers' perception |
|
Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity |
| baseline (Visit 1- Day 1) |
| Lipidomic profile by sampling method (scotch) | By lipidomic analysis | baseline (Visit 1- Day 1) |
| Lipidomic profile by sampling method (extracted comedones) | for acne group only | baseline (Visit 1- Day 1) |
| Acne severity on the face | using Global Acne Evaluation (GEA) scale on a 6-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe) in acne group only | baseline (Visit 1- Day 1) |
| Lesions quantification | by the number of inflammatory lesions (papules and/or pustules) in acne group | baseline (Visit 1- Day 1) |
| Consumers' perception | by a questionnaire about acne skin, skincare routine, needs and expectations in terms of facial care in acne group | baseline (Visit 1- Day 1) |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |