Alopecia, AndrogeneticNCT06854432
Assessment of Biological and Biometrological Parameters in Adult Subjects with Androgenetic Alopecia
A study testing Biometrological measurements and Biological sampling in people with Alopecia, Androgenetic and Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alopecia, Androgenetic, Healthy
- What is being tested?
- Biometrological measurements and Biological sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2024to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Selection criteria:
Criteria related to the population:
- Male
- Subject aged between 30 and 50 years included
Criteria related to the scalp condition:
- Subject with hair length over 3 cm
- Subject presenting a negative pull test result
Specific for non-AGA group:
- Non-alopecic men with full head of hair with uniform scalp coverage (homogeneous hair density on the vertex, occiput, left and right parietal areas)
Specific for AGA group:
- Androgenetic alopecic men with progressive AGA for more than 5 years: stage between III to IV included according to the Hamilton's classification modified by Norwood
Non-selection criteria:
Criteria related to the population:
- Subject having received on study areas artificial UV exposure, excessive or prolonged exposure to natural sunlight within 2 months before the selection visit
- Subjects with frizzy hair
Criteria related to diseases:
- Subject having neoplastic disease (history of disease or disease on-going)
- Subject having severe acute progressive disease (infectious syndromes, inflammatory, COVID-19, acute fever...) occurred within the last 3 months before the selection visit liable to interfere with the study assessments
- Subject with iron deficiency on-going, not treated or treated for less than 3 months before the selection visit
- Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the investigator hazardous for the subject or incompatible with the study requirements
Specific for non-AGA group:
- Subject with any type of alopecia
- Subject with family history of androgenetic alopecia in the father with stage ≥ III according to the Hamilton's classification modified by Norwood
Specific for AGA group:
- Subject with non-androgenetic alopecia (Cicatricial alopecia, Alopecia aerata...)
Criteria related to procedures, treatments, products and/or hair care routine:
- Radiotherapy, chemotherapy
- Scalp surgery
- Systematic or local androgenetic alopecia treatment or product, taken or applied for more than 4 consecutive weeks during the last 6 months before the selection visit
- Any following hair care within the last 3 months before the selection visit: dyeing, bleaching, perm
- Systemic or local non-steroidal anti-inflammatory drug taken or applied on the scalp for more than 1 week during the last month (systematic NSAIDs) or 2 weeks (local NSAIDs) before the selection visit
Non-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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-omics Approaches and Biometrological Analyses to Better Understand Androgenetic Alopecia: Exploratory Study
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.
- Conditions
- Alopecia, Androgenetic, Healthy
- Being tested
- Biometrological measurements, Biological sampling
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometrological measurementsOther
Measurements will be taken from the scalp: on the vertex and occiput areas.
Biological samplingOther
Samples will be taken from the scalp: on the vertex and occiput areas.
| Study group | Role | What they receive |
|---|---|---|
| Control subject group | Other | Not described Receives: Other: Biometrological measurements; Other: Biological sampling |
| Subject group with androgenetic alopecia | Other | Not described Receives: Other: Biometrological measurements; Other: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous pH measurement
Measured: baseline (Visit 1- Day 1)
Sebum quantification : by Lipidic Index (LI) - Sebumeter®
Measured: baseline (Visit 1- Day 1)
Skin elasticity : by determination of the mechanical property of the skin with a biomechanical device
Measured: baseline (Visit 1- Day 1)
Cutaneous hydratation : by Hydratation Index (IH) - DermaLab®
Measured: baseline (Visit 1- Day 1)
Cutaneous barrier integrity : by Trans-Epidermal Water Loss (TEWL) - Vapometer®
Measured: baseline (Visit 1- Day 1)
Lipidomic profile by mass spectroscopy (in-vivo measurements)
Measured: baseline (Visit 1- Day 1)
Lipidomic profile by sampling method (absorbent paper)
Measured: baseline (Visit 1- Day 1)
Microbiota analysis by sampling method (hair follicles)
Measured: baseline (Visit 1- Day 1)
Microbiota analysis by sampling method (swabs)
Measured: baseline (Visit 1- Day 1)
Metabolite analysis by sampling method (hair follicles)
Measured: baseline (Visit 1- Day 1)
Transcriptomic analysis by sampling method (hair follicles)
Measured: baseline (Visit 1- Day 1)
Transcriptomic analysis by sampling method (swabs)
Measured: baseline (Visit 1- Day 1)
Lipidomic profiles by sampling method (swabs)
Measured: baseline (Visit 1- Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start5 Mar 2024
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia, AndrogeneticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854432
- Sponsor's protocol ID
- INTERALOPECIE
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Approaches and Biometrological Analyses to Better Understand Androgenetic Alopecia: Exploratory Study
- ClinicalTrials.gov ID
- NCT06854432
- Acronym / sponsor ID
- INTERALOPECIE
- Conditions
- Alopecia, Androgenetic, Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control subject group | Other | Other: Biometrological measurements, Other: Biological sampling |
| Subject group with androgenetic alopecia | Other | Other: Biometrological measurements, Other: Biological sampling |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biometrological measurementsMeasurements will be taken from the scalp: on the vertex and occiput areas. | Other | Control subject group, Subject group with androgenetic alopecia |
| Biological samplingSamples will be taken from the scalp: on the vertex and occiput areas. | Other | Control subject group, Subject group with androgenetic alopecia |
Primary outcome
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)
Lipidomic profiles by sampling method (swabs)
Time frame: baseline (Visit 1- Day 1)
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biometrological measurements and Biological sampling in people with Alopecia, Androgenetic and Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous pH measurement (time frame: baseline (Visit 1- Day 1)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.