Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia
NCT ID: NCT05802173
Last Updated: 2025-11-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2023-03-06
2024-01-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)
NCT05244980
A Phase 1 Study of TDM-105795 Topical Solution in Male Subjects With Androgenetic Alopecia (AGA)
NCT04913519
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
NCT02280603
A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia
NCT06916793
Minoxidil Response Testing in Males With Androgenetic Alopecia
NCT02198261
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TDM-105795 topical solution, 0.0025%
Daily dose of 0.0025% of TDM-105795 topical solution
TDM-105795, 0.0025%
The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
TDM-105795 topical solution, 0.02%
Daily dose of 0.02% of TDM-105795 topical solution
TDM-105795, 0.02%
The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
TDM-105795 topical vehicle solution
Daily dose of placebo for TDM-105795 topical solution
TDM-105795 topical vehicle solution
The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TDM-105795, 0.0025%
The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
TDM-105795, 0.02%
The assigned drug will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
TDM-105795 topical vehicle solution
The assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Subject is male, 18-55 years old.
2. Subject has provided written informed consent.
3. 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.
4. 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.
5. Subject has normal renal, thyroid, and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
6. 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.
7. Subject is willing to maintain the same hair style, hair length, and hair color throughout the study.
8. 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.
9. Subject is willing and able to apply the investigational product (IP) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
10. Subjects who are sexually active with a female partner and are not surgically sterile ( vasectomy performed at least 6 months prior to treatment) must agree to refrain from sperm donation for at least 90 days after administration of their last dose of IP and inform their non-pregnant female sexual partner to use a highly effective form of birth control1 as described in the informed consent form. Note: Female partner must be confirmed according to subject to be non-pregnant at Visit 1/Screening and Visit 2/Baseline or at the visit when a subject identifies a new sexual partner.
Exclusion Criteria
1. 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.
2. Subject has history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.
3. 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.
4. 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.
5. 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.
6. Subject has a history of scalp reduction or notable trauma with related scarring, hair transplants, and/or hair weaves.
7. Subject has a known or suspected malignancy excluding cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma not located within the treatment area.
8. Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
9. Subject has any condition, which, in the investigator's opinion, would make it unsafe for the subject to participate in this study, including clinically significant abnormal laboratory, or 12-lead electrocardiogram (ECG) findings during the screening period or Visit 2/Baseline prior to dosing of the IP.
10. Subject has used any topical scalp treatments for hair growth including minoxidil, hormone therapy, anti-androgen, or other agents known to affect hair growth within 12 weeks of Visit 2/Baseline.
11. Subject has used any topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene) or hair growth products with saw palmetto, copper, etc. within 4 weeks of Visit 2/Baseline.
12. Subject has used any topical scalp treatments that may have ancillary effects on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within 4 weeks of Visit 2/Baseline.
13. Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months of Visit 2/Baseline.
14. Subject has had platelet rich plasma (PRP) procedures on the scalp at any time.
15. Subject has used systemic beta blockers, cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable. Stable is defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline.
16. Subject has used systemic retinoids, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within 6 months of Visit 2/Baseline.
17. Subject has used finasteride (e.g., Propecia®), dutasteride, minoxidil (oral), or similar products within 6 months of Visit 2/Baseline.
18. Subject has used chemotherapy or cytotoxic agents within 12 months of Visit 2/Baseline.
19. Subject has had radiation of the scalp at any point.
20. Subject has used any other systemic therapy, which in the opinion of the investigator, may materially affect the subject's hair growth, including, but not limited to, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids.
21. Subject is currently enrolled in an investigational drug, biologic, or device study.
22. Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days or 5 half-lives, whichever is longer, prior to Visit 2/Baseline.
23. Subject has previously been treated with the IP.
24. Subject has a history of prescription drug abuse, or illicit drug use within 6 months prior to Visit 1/Screening.
25. Subject has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening.
26. Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or Visit 2/Baseline.
27. Subject has signs or symptoms consistent with Coronavirus Disease-19 (COVID-19) at Visit 1/Screening or Visit 2/Baseline or has been diagnosed with COVID-19 within 4 weeks of Visit 1/Screening.
28. Subject has a history of sensitivity to any of the ingredients in the IP or tattoo ink.
29. Subject is known to be noncompliant or is unlikely to comply with the requirements of t the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
18 Years
55 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Therapeutics, Inc.
INDUSTRY
Technoderma Medicines Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel J. Piacquadio, M.D.
Role: STUDY_DIRECTOR
Therapeutics Incorporated
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 12
North Little Rock, Arkansas, United States
Site 4
Rolling Meadows, Illinois, United States
Site 7
Plainfield, Indiana, United States
Site 11
Baton Rouge, Louisiana, United States
Site 13
New Orleans, Louisiana, United States
Site 10
Minneapolis, Minnesota, United States
Site 9
New Brighton, Minnesota, United States
Site 3
Portland, Oregon, United States
Site 5
Knoxville, Tennessee, United States
Site 8
Murfreesboro, Tennessee, United States
Site 1
Austin, Texas, United States
Site 6
College Station, Texas, United States
Site 2
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
239-11651-203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.