Alopecia, AndrogeneticPhase 2NCT05802173
Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia
A Phase 2 study testing TDM-105795, 0.0025% and TDM-105795, 0.02% in people with Alopecia, Androgenetic, run by Technoderma Medicines Inc. at 13 sites in United States.
Trial summary
Randomized, double-blind, vehicle-controlled, parallel group, multi-dose study of TDM-105795 in male subjects with androgenetic alopecia Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Alopecia, Androgenetic
- What is being tested?
- TDM-105795, 0.0025% and TDM-105795, 0.02%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 13 sitesUnited States
- Study dates
- 6 Mar 2023to 29 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- Subject has used finasteride (e.g., Propecia®), dutasteride, minoxidil (oral), or similar products within 6 months of Visit 2/Baseline.
- Subject has used chemotherapy or cytotoxic agents within 12 months of Visit 2/Baseline.
- Subject has had radiation of the scalp at any point.
- 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.
- Subject is currently enrolled in an investigational drug, biologic, or device study.
- 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.
- Subject has previously been treated with the IP.
- Subject has a history of prescription drug abuse, or illicit drug use within 6 months prior to Visit 1/Screening.
- Subject has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening.
- Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or Visit 2/Baseline.
- 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.
- Subject has a history of sensitivity to any of the ingredients in the IP or tattoo ink.
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Site 1
Austin, Texas, 78759
Site 11
Baton Rouge, Louisiana, 70809
Site 6
College Station, Texas, 77845
Site 5
Knoxville, Tennessee, 37909
Site 10
Minneapolis, Minnesota, 55455
Site 8
Murfreesboro, Tennessee, 37130
Site 9
New Brighton, Minnesota, 55112
Site 13
New Orleans, Louisiana, 70115
Site 2
Norfolk, Virginia, 23502
Site 12
North Little Rock, Arkansas, 72116
Site 7
Plainfield, Indiana, 46168
Site 3
Portland, Oregon, 97210
Site 4
Rolling Meadows, Illinois, 60008
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects With Androgenetic Alopecia
Randomized, double-blind, vehicle-controlled, parallel group, multi-dose study of TDM-105795 in male subjects with androgenetic alopecia
Read the detailed description
Protocol 239-11651-203 is a Phase 2 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects with Androgenetic Alopecia" Eligible subjects will be randomized (1:1:1) to 1 of the 3 groups (low dose vs high dose vs placebo) and treated for 16 weeks.
- Conditions
- Alopecia, Androgenetic
- Being tested
- TDM-105795, 0.0025%, TDM-105795, 0.02%, TDM-105795 topical vehicle solution
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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, 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 vehicle solutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TDM-105795 topical solution, 0.0025% | Experimental | Daily dose of 0.0025% of TDM-105795 topical solution Receives: Drug: TDM-105795, 0.0025% |
| TDM-105795 topical solution, 0.02% | Experimental | Daily dose of 0.02% of TDM-105795 topical solution Receives: Drug: TDM-105795, 0.02% |
| TDM-105795 topical vehicle solution | Placebo comparator | Daily dose of placebo for TDM-105795 topical solution Receives: Drug: TDM-105795 topical vehicle solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-vellus Target Area Hair Count (TAHC)
Collection of non-vellus target area hair count results at week 16
Measured: 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).
Measured: 16 weeks
Secondary outcomes (4)
Change in Non-vellus Target Area Hair Width (TAHW)
Collection of non-vellus target area hair width results at week 16
Measured: 16 weeks
Change in Non-vellus Target Area Hair Darkness (TAHD)
Non-vellus Target Area Hair Darkness (TAHD) results at week 16. Scale is a gray scale, 0(white) to 255(black) measured in a 1 cm2 area. Positive mean change is a better outcome.
Measured: 16 weeks
Hair Growth Index (HGI) Questionnaire
Subject's evaluation of treatment benefit via the hair growth index (HGI) questionnaire at week 16. Scalp hair growth will be compared from Baseline using the following 7-point scale: much less (-3), moderately less (-2), slightly less (-1), the same amount (0), slightly more (1), moderately more (2), and much more (3).
Measured: 16 weeks
Evaluation of Investigator's Global Assessment (IGA) Grade
Collection of IGA grade at week 16. The Canfield Review application will be used. The evaluator will assess the subject's scalp hair growth 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).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start6 Mar 2023
- Primary completion8 Nov 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alopecia, AndrogeneticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technoderma Medicines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel J. Piacquadio, M.D., Study director, Therapeutics Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802173
- Sponsor's protocol ID
- 239-11651-203
- Status last verified
- Nov 2024
- First submitted
- 14 Mar 2023
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT05802173
- Acronym / sponsor ID
- 239-11651-203
- Conditions
- Alopecia, Androgenetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Technoderma Medicines Inc.Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, vehicle-controlled, parallel group, multi-dose study of TDM-105795 in male subjects with androgenetic alopecia
Detailed description
Protocol 239-11651-203 is a Phase 2 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects with Androgenetic Alopecia" Eligible subjects will be randomized (1:1:1) to 1 of the 3 groups (low dose vs high dose vs placebo) and treated for 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TDM-105795 topical solution, 0.0025% | Experimental | Drug: TDM-105795, 0.0025%Daily dose of 0.0025% of TDM-105795 topical solution |
| TDM-105795 topical solution, 0.02% | Experimental | Drug: TDM-105795, 0.02%Daily dose of 0.02% of TDM-105795 topical solution |
| TDM-105795 topical vehicle solution | Placebo comparator | Drug: TDM-105795 topical vehicle solutionDaily dose of placebo for TDM-105795 topical solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | TDM-105795 topical solution, 0.0025% |
| 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. | Drug | TDM-105795 topical solution, 0.02% |
| TDM-105795 topical vehicle solutionThe assigned placebo will be applied once daily for 16 weeks, with application to the scalp focusing on the regions that are bald and thinning. | Drug | TDM-105795 topical vehicle solution |
Primary outcome
Non-vellus Target Area Hair Count (TAHC)
Time frame: 16 weeks
Collection of non-vellus target area hair count results at week 16
Evaluation of Treatment Benefit
Time frame: 16 weeks
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).
4 secondary outcomes
Change in Non-vellus Target Area Hair Width (TAHW)
Time frame: 16 weeks
Change in Non-vellus Target Area Hair Darkness (TAHD)
Time frame: 16 weeks
Hair Growth Index (HGI) Questionnaire
Time frame: 16 weeks
Evaluation of Investigator's Global Assessment (IGA) Grade
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alopecia, Androgenetic
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Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J. Piacquadio, M.D. study director
Therapeutics Incorporated
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TDM-105795, 0.0025% and TDM-105795, 0.02% in people with Alopecia, Androgenetic, run by Technoderma Medicines Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-vellus Target Area Hair Count (TAHC) (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.