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

NCT ID: NCT06841393

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-01-17

Brief Summary

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.

Conditions

Acne; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control subject group

Group Type: OTHER

Biometrological measurements

Intervention Type: OTHER

Measurements will be taken from the face:

• For acne group: inflammatory lesional area and non-lesional area
• For control group: non-lesional area

Biological sampling

Intervention Type: OTHER

Samples will be taken from the face:

• For acne group: inflammatory lesional area, non-lesional area and retentional area
• For control group: non-lesional area

Subject group with mild to moderate acne on the face

Group Type: OTHER

Biometrological measurements

Intervention Type: OTHER

Measurements will be taken from the face:

• For acne group: inflammatory lesional area and non-lesional area
• For control group: non-lesional area

Biological sampling

Intervention Type: OTHER

Samples will be taken from the face:

• For acne group: inflammatory lesional area, non-lesional area and retentional area
• For control group: non-lesional area

Clinical assessments

Intervention Type: OTHER

Only for acne group: acne scores will be evaluated on the face by the investigator

Questionnaire

Intervention Type: OTHER

Only for acne group: consumers' perception

Interventions

Biometrological measurements

Measurements will be taken from the face:

• For acne group: inflammatory lesional area and non-lesional area
• For control group: non-lesional area

Intervention Type: OTHER

Biological sampling

Samples will be taken from the face:

• For acne group: inflammatory lesional area, non-lesional area and retentional area
• For control group: non-lesional area

Intervention Type: OTHER

Clinical assessments

Only for acne group: acne scores will be evaluated on the face by the investigator

Intervention Type: OTHER

Questionnaire

Only for acne group: consumers' perception

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skin Research Center

Toulouse, , France

Countries

France

Other Identifiers

INTERACNE

Identifier Type: -

Identifier Source: org_study_id