NCT06854432

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 21, 2025

Last Update Submit

February 26, 2025

Conditions

Alopecia, AndrogeneticHealthy

Outcome Measures

Primary Outcomes (13)

  • 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)

Study Arms (2)

Control subject group

OTHER
Other: Biometrological measurementsOther: Biological sampling

Subject group with androgenetic alopecia

OTHER
Other: Biometrological measurementsOther: Biological sampling

Interventions

Biometrological measurementsOTHER

Measurements will be taken from the scalp: on the vertex and occiput areas.

Control subject groupSubject group with androgenetic alopecia
Biological samplingOTHER

Samples will be taken from the scalp: on the vertex and occiput areas.

Control subject groupSubject group with androgenetic alopecia

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Criteria related to the population:
  • Criteria related to the disease:
  • Criteria related to treatments and/or products:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Research Center

Toulouse, 31100, France

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

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 21, 2025

First Posted

March 3, 2025

Study Start

March 5, 2024

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

FR(1)