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A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects With Androgenetic Alopecia (AGA)

NCT05244980•Technoderma Medicines Inc.

View on ClinicalTrials.gov

Summary

Multi-center, randomized, double-blind, vehicle-controlled, parallel group, multi-dose escalation study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic Alopecia (AGA).

Detailed Description

Protocol 239-11651-102 is a planned Phase 1 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects with Androgenetic Alopecia". Eligible subjects will be assigned to a sequential treatment cohort and will receive either one of the TDM-105795 solutions or the Placebo. The assigned test article will be applied once daily onto the scalp in the hair loss area (e.g., top of head and temple areas). All subjects will be treated with 1 mL/dose of test article with application to the scalp focusing on the regions that are bald and thinning.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•To enter the study, a subject must meet the following criteria:
•1. Subject is male, 18-55 years old.
•2. Subject has provided written informed consent.
•3. Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, III to VI on the Modified Norwood-Hamilton Scale (i.e., III, IV, V, and VI).
•4. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
•5. 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.
•6. Subject has normal renal, thyroid, and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
•7. 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 6 months before Visit 2/Baseline.
•8. Subject has a body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 kg at Visit 1/Screening.
•9. 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.
+1 more criteria

Exclusion Criteria

•A subject is ineligible to enter the study if he meets 1 or more of the following 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 test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
•2. 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 test article or requires use of interfering topical, systemic, or surgical therapy.
•3. 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.
•4. Subject has a history of scalp reduction or notable trauma with related scarring, hair transplants, and/or hair weaves.
•5. Subject has a known or suspected malignancy.
•6. Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
•7. 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 test article.
•8. Subject has a hospital admission or major surgery within 30 days prior to Visit 2/ Baseline or planned for during the study.
•9. Subject is currently enrolled in an investigational drug, biologic, or device study.
+9 more criteria

Locations (2)

TCR Medical Corporation

San Diego, California, United States

J&S Studies, Inc.

College Station, Texas, United States

Key Dates

Start Date

February 1, 2022

Primary Completion Date

November 15, 2022

Completion Date

February 27, 2023

Last Updated

March 14, 2023

Enrollment

ACTUAL participants

Conditions

Alopecia, Androgenetic

Interventions

TDM-105795

DRUG

Placebo

DRUG

A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

NCT07011485

Alopecia, AndrogeneticBaldness+1 more

View study

COMPLETEDPHASE3

Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia

NCT05296863

Alopecia, AndrogeneticHair Loss/Baldness

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)

Inclusion Criteria

Exclusion Criteria

A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia

Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)