Assessment of Biological, Biometrological Parameters and Consumer Needs in Adult Subjects with Acne

Pierre Fabre

Status

Terminated

Conditions

Healthy

Acne

Treatments

Other: Biometrological measurements

Other: Biological sampling

Other: Questionnaire

Other: Clinical assessments

Study type

Interventional

Funder types

Industry

Identifiers

NCT06841393

INTERACNE

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inlcusion criteria:

Criteria related to the population:

Subject aged between 18 and 30 years included
For women of childbearing potential: use of an effective method of contraception, as assessed by the investigator, introduced and unchanged for at least 3 months before inclusion in the study

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:

For women of childbearing potential: pregnant or breastfeeding
Subject having received on face artificial UV exposure, excessive or prolonged exposure to natural sunlight within 4 weeks before the inclusion visit
Subject with facial hair liable to interfere with the study assessments

Criteria related to the disease:

Clinical signs of hormone dysfunction or hyperandrogenism
Severe form of acne (acne conglobata, acne fulminans or nodulocystic acne) or acneiform eruptions, in the investigator's opinion
Sunburn on the face due to excessive UV exposure

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:

Subject with significant acne lesions according to investigator assessment
Subject having any inflammatory face dermatosis

Criteria related to treatments and/or products:

Any surgery, chemical or physical treatment on the face in the 12 months before the inclusion visit
Systemic isotretinoin treatment taken in the 6 months prior before the inclusion visit
Systemic acne treatment taken in the 3 months before the inclusion visit
Probiotics taken orally in the month before the inclusion visit
Topical acne treatment applied to the face in the month before the inclusion visit
Topical or Systemic Non-Steroidal Anti-Inflammatory (NSAI), corticosteroids, taken or applied to the face in the 2 weeks before the inclusion visit
Skincare product for acne liable to interfere with the study according to investigator's assessment applied to the face in the 2 weeks before the inclusion visit