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Clinical Trials/NCT06854432
NCT06854432TerminatedNot Applicable

Multi-omics Approaches and Biometrological Analyses to Better Understand Androgenetic Alopecia: Exploratory Study

Pierre Fabre Dermo Cosmetique1 site in 1 country46 target enrollmentStarted: March 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
46
Locations
1
Primary Endpoint
Lipidomic profiles by sampling method (swabs)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
30 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Criteria related to the population:
  • •Subject having received on study areas artificial UV exposure, excessive or prolonged exposure to natural sunlight between selection and inclusion visit
  • •Criteria related to the disease:
  • •Subject with any adverse event occurring between selection and inclusion visit liable to interfere with the study assessments
  • •Criteria related to treatments and/or products:
  • •Any procedures, treatments, products and/or hair care taken, applied or performed between selection and inclusion visit liable to interfere with the study assessments

Exclusion Criteria

  • Not provided

Arms & Interventions

Control subject group

Other

Intervention: Biometrological measurements (Other)

Control subject group

Other

Intervention: Biological sampling (Other)

Subject group with androgenetic alopecia

Other

Intervention: Biometrological measurements (Other)

Subject group with androgenetic alopecia

Other

Intervention: Biological sampling (Other)

Outcomes

Primary Outcomes

Lipidomic profiles by sampling method (swabs)

Time Frame: baseline (Visit 1- Day 1)

Cutaneous pH measurement

Time Frame: baseline (Visit 1- Day 1)

Sebum quantification : by Lipidic Index (LI) - Sebumeter®

Time Frame: baseline (Visit 1- Day 1)

Skin elasticity : by determination of the mechanical property of the skin with a biomechanical device

Time Frame: baseline (Visit 1- Day 1)

Cutaneous hydratation : by Hydratation Index (IH) - DermaLab®

Time Frame: baseline (Visit 1- Day 1)

Cutaneous barrier integrity : by Trans-Epidermal Water Loss (TEWL) - Vapometer®

Time Frame: baseline (Visit 1- Day 1)

Lipidomic profile by mass spectroscopy (in-vivo measurements)

Time Frame: baseline (Visit 1- Day 1)

Lipidomic profile by sampling method (absorbent paper)

Time Frame: baseline (Visit 1- Day 1)

Microbiota analysis by sampling method (hair follicles)

Time Frame: baseline (Visit 1- Day 1)

Microbiota analysis by sampling method (swabs)

Time Frame: baseline (Visit 1- Day 1)

Metabolite analysis by sampling method (hair follicles)

Time Frame: baseline (Visit 1- Day 1)

Transcriptomic analysis by sampling method (hair follicles)

Time Frame: baseline (Visit 1- Day 1)

Transcriptomic analysis by sampling method (swabs)

Time Frame: baseline (Visit 1- Day 1)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Pierre Fabre Dermo Cosmetique
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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