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

Knowledge and Exploratory Study to Better Understand Face Acne Pathophysiology and Acne Lesion Severity by Multi-omic Approaches, Biometrological Analysis and Consumer Needs

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.

Study Overview

• Status: Terminated
• Conditions: Healthy; Acne
• Intervention / Treatment: Other: Biometrological measurements; Other: Biological sampling; Other: Clinical assessments; Other: Questionnaire

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • Skin Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control subject group	Other: 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; 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
Other: Subject group with mild to moderate acne on the face	Other: 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; 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; Other: Clinical assessments; Only for acne group: acne scores will be evaluated on the face by the investigator; Other: Questionnaire; Only for acne group: consumers' perception

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: INTERACNE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No