Clinical trial NCT06841393: Assessment of Biological, Biometrological Parameters and Consumer Needs in Adult Subjects with Acne
Official title: Knowledge and Exploratory Study to Better Understand Face Acne Pathophysiology and Acne Lesion Severity by Multi-omic Approaches, Biometrological Analysis and Consumer Needs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acne
Healthy
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Cutaneous pH measurement
timeFrame: baseline (Visit 1- Day 1)
measure: Sebum quantification
timeFrame: baseline (Visit 1- Day 1)
measure: Cutaneous barrier integrity
timeFrame: baseline (Visit 1- Day 1)
measure: Epigenetic analysis by sampling method (urine)
timeFrame: baseline (Visit 1- Day 1)
measure: Microbiota profile by sampling method (swabs)
timeFrame: baseline (Visit 1- Day 1)
measure: Microbiota profile by sampling method (extracted comedones)
timeFrame: baseline (Visit 1- Day 1)
measure: Metabolomic profile by sampling method (swabs)
timeFrame: baseline (Visit 1- Day 1)
measure: Metabolomic profile by sampling method (extracted comedones)
timeFrame: baseline (Visit 1- Day 1)
measure: Lipidomic profile by mass spectroscopy (in-vivo measurements)
timeFrame: baseline (Visit 1- Day 1)
measure: Lipidomic profile by sampling method (scotch)
timeFrame: baseline (Visit 1- Day 1)
measure: Lipidomic profile by sampling method (extracted comedones)
timeFrame: baseline (Visit 1- Day 1)
measure: Acne severity on the face
timeFrame: baseline (Visit 1- Day 1)
measure: Lesions quantification
timeFrame: baseline (Visit 1- Day 1)
measure: Consumers' perception
timeFrame: baseline (Visit 1- Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Skin Research Center
Study officials:
References: