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

NCT05802173 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 239-11651-203
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Alopecia, Androgenetic

Outcome Measures

Primary Outcomes (2)

• Non-vellus Target Area Hair Count (TAHC)

  Collection of non-vellus target area hair count results at week 16

  16 weeks

• Evaluation of Treatment Benefit

  Collection of hair growth assessment (HGA) questionnaire at week 16. Scalp hair growth will be compared from Baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).

  16 weeks

Secondary Outcomes (4)

• Change in Non-vellus Target Area Hair Width (TAHW)

  16 weeks

• Change in Non-vellus Target Area Hair Darkness (TAHD)

  16 weeks

• Hair Growth Index (HGI) Questionnaire

  16 weeks

• Evaluation of Investigator's Global Assessment (IGA) Grade

  16 weeks

Other Outcomes (2)

• Number of Participants With Any Local and Systemic Adverse Events (AEs)

  20 weeks

• Number of Subjects With Presence (and Severity) of Local Skin Reactions (LSRs)

  16 weeks

Study Arms (3)

TDM-105795 topical solution, 0.0025%

EXPERIMENTAL

Daily dose of 0.0025% of TDM-105795 topical solution

Drug: TDM-105795, 0.0025%

TDM-105795 topical solution, 0.02%

EXPERIMENTAL

Daily dose of 0.02% of TDM-105795 topical solution

Drug: TDM-105795, 0.02%

TDM-105795 topical vehicle solution

PLACEBO COMPARATOR

Daily dose of placebo for TDM-105795 topical solution

Drug: TDM-105795 topical vehicle solution

Interventions

TDM-105795, 0.0025% DRUG

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, 0.0025%

TDM-105795, 0.02% DRUG

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%

TDM-105795 topical vehicle solution DRUG

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.

TDM-105795 topical vehicle solution

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To enter the study, a subject must meet the following 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.
• 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.
• 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.

You may not qualify if:

• A subject is ineligible to enter the study if he meets 1 or more of the following 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.
• 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.
• 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.
• 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.
• 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.
• Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, etc. within 6 months of Visit 2/Baseline.
• Subject has had platelet rich plasma (PRP) procedures on the scalp at any time.

Sponsors & Collaborators

• Technoderma Medicines Inc.: lead
• Therapeutics, Inc.: collaborator

Study Sites (13)

Site 12

North Little Rock, Arkansas, 72116, United States

Location

Site 4

Rolling Meadows, Illinois, 60008, United States

Location

Site 7

Plainfield, Indiana, 46168, United States

Location

Site 11

Baton Rouge, Louisiana, 70809, United States

Location

Site 13

New Orleans, Louisiana, 70115, United States

Location

Site 10

Minneapolis, Minnesota, 55455, United States

Location

Site 9

New Brighton, Minnesota, 55112, United States

Location

Site 3

Portland, Oregon, 97210, United States

Location

Site 5

Knoxville, Tennessee, 37909, United States

Location

Site 8

Murfreesboro, Tennessee, 37130, United States

Location

Site 1

Austin, Texas, 78759, United States

Location

Site 6

College Station, Texas, 77845, United States

Location

Site 2

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Arthur P. Bertolino MD, PhD, MBA Chief Medical Officer
• Organization: Technoderma Medicines

arthur.bertolino@innovationderm.com

+1.616.928.1145

Study Officials

• Daniel J. Piacquadio, M.D.

  Therapeutics Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 6, 2023
• Study Start: March 6, 2023
• Primary Completion: November 8, 2023
• Study Completion: January 29, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2024-11

Locations

US (13)