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

Not Applicable

Terminated

• Conditions: Acne; Healthy

• Registration Number: NCT06841393
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cutaneous pH measurement	baseline (Visit 1- Day 1)	by pH - pHmeter
Sebum quantification	baseline (Visit 1- Day 1)	by Lipidic Index (LI) - Sebumeter®
Epigenetic analysis by sampling method (urine)	baseline (Visit 1- Day 1)
Lipidomic profile by sampling method (scotch)	baseline (Visit 1- Day 1)	By lipidomic analysis
Cutaneous barrier integrity	baseline (Visit 1- Day 1)	by Trans-Epidermal Water Loss (TEWL) - Aquaflux®
Microbiota profile by sampling method (extracted comedones)	baseline (Visit 1- Day 1)	for acne group only
Microbiota profile by sampling method (swabs)	baseline (Visit 1- Day 1)	By non-targeting metagenomics
Metabolomic profile by sampling method (extracted comedones)	baseline (Visit 1- Day 1)	for acne group only
Lipidomic profile by mass spectroscopy (in-vivo measurements)	baseline (Visit 1- Day 1)	Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Metabolomic profile by sampling method (swabs)	baseline (Visit 1- Day 1)	By metabolomic analysis
Acne severity on the face	baseline (Visit 1- Day 1)	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
Lipidomic profile by sampling method (extracted comedones)	baseline (Visit 1- Day 1)	for acne group only
Lesions quantification	baseline (Visit 1- Day 1)	by the number of inflammatory lesions (papules and/or pustules) in acne group
Consumers' perception	baseline (Visit 1- Day 1)	by a questionnaire about acne skin, skincare routine, needs and expectations in terms of facial care in acne group

Trial Locations

Locations (1)

Skin Research Center; 🇫🇷 Toulouse, France