Assessment of Biological and Biometrological Parameters in Adult Subjects with Androgenetic Alopecia

Not Applicable

Terminated

• Conditions: Alopecia, Androgenetic; Healthy

• Registration Number: NCT06854432
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

Brief Summary

Androgenetic alopecia is a chronic pathology affecting approximately 50% of men at 50 years old and is characterized by a progressive miniaturization of the hair follicle leading to a localized baldness.

Although it has been shown that testosterone metabolism plays a central role in this pathology, targeting this biological pathway is not fully efficient to treat androgenetic alopecia, suggesting that other factors are involved, notably factors linked to the perifollicular environment. Moreover, the very specific pattern of androgenetic alopecia is not yet fully understood: the occipital and lower temporal areas of the scalp are always preserved. Once the hair follicle has disappeared, it is not possible to make it grow back, it is then important to provide a treatment that slows down the progression of androgenetic alopecia at the earliest stage of the pathology, and that specifically targets the affected area.

The aim of this study is to better understand androgenetic alopecia pathophysiology by a multi-omic approaches and biometrological analysis, in the same study, on the local ecosystem of bald scalp areas and non-bald scalp areas of adult with androgenetic alopecia, compared to scalp of adult without androgenetic alopecia.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-05
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Status Verified: 2025-02
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 46

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)
Sebum quantification : by Lipidic Index (LI) - Sebumeter®	baseline (Visit 1- Day 1)
Skin elasticity : by determination of the mechanical property of the skin with a biomechanical device	baseline (Visit 1- Day 1)
Cutaneous hydratation : by Hydratation Index (IH) - DermaLab®	baseline (Visit 1- Day 1)
Cutaneous barrier integrity : by Trans-Epidermal Water Loss (TEWL) - Vapometer®	baseline (Visit 1- Day 1)
Lipidomic profile by mass spectroscopy (in-vivo measurements)	baseline (Visit 1- Day 1)
Lipidomic profile by sampling method (absorbent paper)	baseline (Visit 1- Day 1)
Microbiota analysis by sampling method (hair follicles)	baseline (Visit 1- Day 1)
Microbiota analysis by sampling method (swabs)	baseline (Visit 1- Day 1)
Metabolite analysis by sampling method (hair follicles)	baseline (Visit 1- Day 1)
Transcriptomic analysis by sampling method (hair follicles)	baseline (Visit 1- Day 1)
Transcriptomic analysis by sampling method (swabs)	baseline (Visit 1- Day 1)
Lipidomic profiles by sampling method (swabs)	baseline (Visit 1- Day 1)

Trial Locations

Locations (1)

Skin Research Center; 🇫🇷 Toulouse, France