CompletedPhase 2

Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia

United States71 participantsStarted 2023-03-06

Plain-language summary

Randomized, double-blind, vehicle-controlled, parallel group, multi-dose study of TDM-105795 in male subjects with androgenetic alopecia

Who can participate

Age range18 Years – 55 Years

SexMALE

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Inclusion criteria

✓. Subject is male, 18-55 years old.
✓. Subject has provided written informed consent.
✓. Subject has a clinical diagnosis of mild to moderate androgenetic alopecia (AGA) in temple and vertex region with a score of IIIv, IV, or V on the Modified Norwood-Hamilton Scale.
✓. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of AGA or exposes the subject to an unacceptable risk by study participation.
✓. Subject has normal renal, thyroid, and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
✓. Subject is a non-smoker, defined as not having smoked or used any form of tobacco or non-tobacco products containing nicotine in more than 4 months before Visit 2/Baseline.
✓. Subject is willing to maintain the same hair style, hair length, and hair color throughout the study.
✓. Subject agrees to continue his other general hair care products and regimen for at least 2 weeks prior to Visit 2/Baseline, and through the entire study.

Exclusion criteria

✕. Subject has any dermatological disorders of the scalp on the regions that are bald and thinning with the possibility of interfering with the application of the IP or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
✕. Subject has history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.
✕. Subject has any skin pathology or condition (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns) that, in the investigator's opinion, could interfere with the evaluation of the IP or requires use of interfering topical, systemic, or surgical therapy.
✕. Subject has any visible inflammatory skin disease, injury, or condition of their scalp that could compromise subject safety and/or interfere with the evaluation of local or systemic assessments performed during the study.
✕. Subject has history (within 6 months of Visit 1/Screening) of severe dietary or weight changes or history of eating disorder(s), which has resulted in hair loss, in the opinion of the investigator.
✕. Subject has a history of scalp reduction or notable trauma with related scarring, hair transplants, and/or hair weaves.
✕. Subject has a known or suspected malignancy excluding cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma not located within the treatment area.
✕. Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.

What they're measuring

Non-vellus Target Area Hair Count (TAHC)

Timeframe: 16 weeks

Evaluation of Treatment Benefit

Timeframe: 16 weeks

Trial details

NCT IDNCT05802173

SponsorTechnoderma Medicines Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-08

Results submitted2025-10-10

View on ClinicalTrials.gov More Alopecia, Androgenetic trials