Status:
COMPLETED
Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Androgenic Alopecia
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Alopecia involves a diminution of visible hair that can have significant psychosocial effects and impairment of quality of life. There are numerous types of alopecia, among them, androgenic alopecia (...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Male
- Subject requiring hair transplant with micrografts (strip technique or FUE technique)
- Subject aged ≥ 18 years old
- Subject having androgenetic alopecia selected by the investigator for a hair transplant
- Main non-inclusion criteria:
- Subject having any other hair disorder or hair disease (telogen effluvium, alopecia areata, cicatricial alopecia, hair shaft disorder, trichotillomania…) and liable to interfere with the study assessments
- Subject having dermatological pathology or evolutive skin lesion on the scalp (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, …)
- Iron deficiency (confirmation by ferritin assay results from less than 3 months performed during preoperative assessment)
- Thyroid disorders (confirmation by thyroid hormon assay results from less than 3 months performed during preoperative assessment)
- Systemic treatment with antithyroid or iron supplement established or modified within 3 months before the inclusion or planned during the study
- Radiotherapy or chemotherapy at any time before the inclusion or planned during the study
- Systemic anti-hair loss treatment (anti-androgenic treatments…) established or modified within 6 months before the inclusion visit or planned during the study
- Topical anti-hair loss treatment (Minoxidil…) established or modified within 3 months before the inclusion visit or planned during the study
- Any other systemic treatment (cardiovascular, endocrine, antidepressant, antipsychotic, …) established or modified during the previous weeks before the inclusion or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the products according to the investigator's assessment
- Any other topical treatment or product applied on the scalp within previous weeks before the inclusion or planned during the study that can limit the effectiveness of the transplant and liable to interfere with the study assessments, according to the investigator's opinion
Exclusion
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06576492
Start Date
July 5 2021
End Date
June 12 2023
Last Update
August 28 2024
Active Locations (1)
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1
Instituto Medico Ricart
Madrid, Chamartin, Spain, 28046