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Topical TDM-105795 for Male Pattern Baldness
Phase 2
Waitlist Available
Research Sponsored by Technoderma Medicines Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 is male, 18-55 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
Study Summary
This trial tested a drug for male hair loss using a blind, scientific study with multiple doses.
Who is the study for?
This trial is for males aged 18-55 with mild to moderate male pattern baldness, specifically in the temple and vertex regions. Participants must be in good health with normal kidney, thyroid, and liver function. They should not smoke or use nicotine products and agree to maintain their hair style and color throughout the study. Sexually active participants must use birth control.Check my eligibility
What is being tested?
The study tests TDM-105795 at different concentrations (0.0025%, 0.02%) against a placebo solution for treating male pattern baldness. It's randomized, meaning subjects are assigned treatment by chance; double-blind, so neither researchers nor participants know who gets what; vehicle-controlled comparing an inactive substance; parallel group where each group receives one treatment.See study design
What are the potential side effects?
Potential side effects of TDM-105795 are not specified here but could include skin irritation or allergic reactions at the site of application given it's a topical medication being tested on individuals with alopecia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild to moderate hair loss on the top and sides of my head.
Select...
I am a man aged between 18 and 55.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in non-vellus target area hair count (TAHC)
Evaluation of treatment benefit
Secondary outcome measures
Change in non-vellus target area hair darkness (TAHD)
Change in non-vellus target area hair width (TAHW)
Evaluation of investigator's global assessment (IGA) grade
+1 moreOther outcome measures
Incidence (severity and causality) of any local and systemic adverse events (AEs)
Number of participants with abnormal BMI
Number of participants with abnormal ECG readings
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TDM-105795 topical solution, 0.02%Experimental Treatment1 Intervention
Daily dose of 0.02% of TDM-105795 topical solution
Group II: TDM-105795 topical solution, 0.0025%Experimental Treatment1 Intervention
Daily dose of 0.0025% of TDM-105795 topical solution
Group III: TDM-105795 topical vehicle solutionPlacebo Group1 Intervention
Daily dose of placebo for TDM-105795 topical solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TDM-105795, 0.0025%
2023
Completed Phase 2
~80
TDM-105795, 0.02%
2023
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Therapeutics, Inc.Industry Sponsor
30 Previous Clinical Trials
3,841 Total Patients Enrolled
Technoderma Medicines Inc.Lead Sponsor
4 Previous Clinical Trials
144 Total Patients Enrolled
Daniel J. Piacquadio, M.D.Study DirectorTherapeutics Incorporated
2 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mild to moderate hair loss on the top and sides of my head.I haven't used any hair growth products like Aminexil or Nioxin in the last 4 weeks.I have experienced hair loss due to conditions other than male/female pattern baldness.I have received radiation treatment on my scalp.I have used hair loss treatments like finasteride or minoxidil in the last 6 months.My kidney, liver, and thyroid functions are normal according to my recent tests.I have cancer, but it's not skin cancer in the area being treated.I haven't taken isotretinoin, high-dose vitamin A, or cyclosporine in the last 6 months.I have not had any scalp treatments in the last 6 months.I haven't used any experimental treatments in the last 30 days or 5 half-lives.I am able to follow the study's requirements.I have used chemotherapy or similar treatments within the last year.I haven't used any treatments that could affect my hair growth, including vitamins or steroids.I am a man aged between 18 and 55.I do not have any skin conditions on my scalp that could affect the study.I have had PRP treatments on my scalp.I have been treated with the investigational product before.You have had significant changes in your diet or weight, or a history of eating disorders that have caused hair loss within the past 6 months.I haven't used any hair growth treatments on my scalp in the last 12 weeks.I have symptoms of COVID-19 or was diagnosed with it in the last 4 weeks.You have a skin condition or thyroid disease that could affect the study, or you need to use treatments that could interfere with the study.I agree to not change my hair style, length, or color during the study.You have tested positive for HIV, hepatitis B, or hepatitis C in a blood test.You tested positive for alcohol or drugs during the initial screening or baseline visit.I agree to not change my hair care routine for 2 weeks before my next visit and during the study.You have not used any tobacco or nicotine products for more than 4 months before the start of the study.I am willing and able to follow the study's treatment plan and attend all appointments.I do not have skin conditions on my scalp that could affect treatment application or assessment.I have had scalp surgery, significant head injury, hair transplants, or weaves.I haven't used any scalp treatments affecting hair growth in the last 4 weeks.I haven't taken certain medications like beta blockers or steroids in the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: TDM-105795 topical solution, 0.0025%
- Group 2: TDM-105795 topical solution, 0.02%
- Group 3: TDM-105795 topical vehicle solution
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Male Pattern Baldness Patient Testimony for trial: Trial Name: NCT05802173 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What implications will there be for patients that use TDM-105795 topical solution, 0.0025%?
"Considering its Phase 2 status, there is some evidence of TDM-105795 topical solution 0.0025%'s safety but no data to support the efficacy; thus it has been allocated a score of 2."
Answered by AI
Is eligibility limited to individuals aged 75 or younger for this experiment?
"To be eligible for this medical study, patients must fit the age bracket of 18 to 55. 12 trials that are suitable for people younger than 18 and 59 studies fitting those over 65 years old are also available."
Answered by AI
What are the eligibility criteria for participation in this investigation?
"To partake in this medical trial, candidates must have male pattern baldness and be between 18-55 years old. A maximum of 72 participants will be enrolled in the study."
Answered by AI
Are enrollment opportunities still available for this research project?
"Accurate. According to clinicaltrials.gov, recruitment for this particular trial is not open at the moment since it was last updated on March 26th 2023. However, there are 83 other experiments that are currently recruiting individuals for study participation."
Answered by AI
What goals is this research endeavor striving to achieve?
"Per the clinical trial sponsor, Technoderma Medicines Inc., the primary purpose of this 16-week experiment is to observe treatment efficacy. Secondary goals include assessing non-vellus target area hair darkness (TAHD) at week 16 and evaluating patient satisfaction with their results through a Hair Growth Index (HGI) questionnaire. Scalp hair growth will be measured via Canfield Review application using a 7 point scale ranging from much less (-3), moderately less (-2), slightly less (-1), same amount (0), slightly more (1), moderately more (2) to much more(3). Similarly, investigators' global assessment grade's"
Answered by AI
Who else is applying?
What site did they apply to?
Virginia Clinical Research, Inc.
Site 12
Site 4
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
0
What state do they live in?
Arkansas
Why did patients apply to this trial?
Would like to have thicker hair and stop hair loss. I want to help scientific research on AGA progress further.
PatientReceived 1 prior treatment
I've all kinds of hair growth items in my life and finally just shave my head .
PatientReceived 2+ prior treatments
I have had alopecia for almost 20 years. I have tried the usual regimens, but nothing has worked. I am hoping this will.
PatientReceived 1 prior treatment
I’m tired of hiding under my hat for so many years. Having hair would absolutely change my life, and I hope this trial can help me with that.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Site 6: < 24 hours
- Virginia Clinical Research, Inc.: < 24 hours
Typically responds via
Email
Average response time
- < 1 Day
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