Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia (NCT05802173) | Clinical Trial Compass
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 range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.