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

NCT06841393 | Terminated

• 1 other identifier: INTERACNE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (14)

• 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)

  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)

Study Arms (2)

Control subject group

OTHER

Other: Biometrological measurements; Other: Biological sampling

Subject group with mild to moderate acne on the face

OTHER

Other: Biometrological measurements; Other: Biological sampling; Other: Clinical assessments; Other: Questionnaire

Interventions

Biometrological measurements OTHER

Measurements will be taken from the face: * For acne group: inflammatory lesional area and non-lesional area * For control group: non-lesional area

Control subject group; Subject group with mild to moderate acne on the face

Biological sampling 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

Control subject group; Subject group with mild to moderate acne on the face

Clinical assessments OTHER

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

Subject group with mild to moderate acne on the face

Questionnaire OTHER

Only for acne group: consumers' perception

Subject group with mild to moderate acne on the face

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Criteria related to the population:
• For women of childbearing potential: pregnant or breastfeeding
• 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:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Center

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: October 16, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

FR (1)