Alopecia, AndrogeneticPhase 1AGANCT04913519
A Phase 1 Study of TDM-105795 Topical Solution in Male Subjects With Androgenetic Alopecia (AGA)
A Phase 1 study testing TDM-105795 in people with Alopecia, Androgenetic, run by Technoderma Medicines Inc. at 2 sites in United States.
Trial summary
Multi-center, fixed volume, randomized, double-blind, vehicle-controlled, parallel group, dose escalation comparison study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic Alopecia (AGA). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alopecia, Androgenetic
- What is being tested?
- TDM-105795
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2021to 31 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- 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 moderate to severe AGA in temple and vertex region, IIIv to VI on the Modified Norwood-Hamilton Scale (i.e., IIIv, IV, V, and VI).
- 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.
- 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.
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- 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 6 months before Visit 2/Baseline.
- 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.
- 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.
- 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 1 week following initiation of study treatment and inform their female sexual partner to use a highly effective form of birth control as described in the informed consent form. For females, highly effective forms of birth control include 1) intrauterine device (IUD; copper or hormonal); 2) implantable hormonal contraception; 3) surgical sterilization (i.e., hysterectomy, tubal ligation, or bilateral oophorectomy) performed at least 6 months prior to the subject's study entry; 4) total abstinence; or 5) using one of each of the following a) hormonal contraceptives [other than IUD or implantable, e.g., oral, transdermal, injectable, or vaginal ring] and b) double barrier methods [i.e., male or female condom, diaphragm with spermicidal foam/gel/film/cream/vaginal suppository, cervical cap with spermicides, or contraceptive sponge]. Male subjects who become sexually active or begin to have relations with a female partner who is not sterile during the trial must have a female partner who agrees to use a highly effective form of birth control for the duration of the subject's participation in the trial. Female partner taking hormonal therapy must be on treatment prior to the subject's entry into the study, continued per label, and must not change their dosing regimen during the trial; highly effective birth control forms must be for (1) oral: at least 1 complete cycle (e.g., 4 to 8 weeks); (2) transdermal, injectable (e.g., Depo-Provera), implantable, vaginal ring (e.g., NuvaRing), IUD: at least 1 week; or (3) total abstinence: at least 1 complete cycle (e.g., 4 to 8 weeks) prior to initiation of test article. For males, adequate forms of contraception include condom and spermicide in combination with other forms of female contraception.
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 test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
- 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.
- 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 a history of scalp reduction or notable trauma with related scarring, hair transplants, and/or hair weaves.
- Subject has a known or suspected malignancy.
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- 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 test article.
- Subject has a hospital admission or major surgery within 30 days prior to Visit 2/ Baseline or planned for during the study.
- 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 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 a donation or blood collection of more than 1 unit (approximately 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to Visit 2/Baseline.
- Subject has used prescription or over-the-counter (OTC) medications, or herbal (including St John's Wort, herbal teas, garlic extracts) supplements within 14 days prior to dosing at Visit 2/Baseline. (Note: Use of acetaminophen at < 3g/day is permitted until 24 hours prior to dosing at Visit 2/Baseline).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
J&S Studies, Inc.
College Station, Texas, 77845
TCR Medical Corporation
San Diego, California, 92123
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Dose TDM-105795 Topical Solution in Healthy Male Subjects With AGA
Multi-center, fixed volume, randomized, double-blind, vehicle-controlled, parallel group, dose escalation comparison study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic Alopecia (AGA).
Read the detailed description
Protocol 239-11651-101 is a planned Phase 1 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 Following a Fixed-Volume Topical Single Administration 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 onto the scalp in the hair loss area (e.g., top of head and temple areas). All subjects will be treated with 1 mL of test article with application to the scalp focusing on the regions that are bald and thinning.
- Conditions
- Alopecia, Androgenetic
- Being tested
- TDM-105795, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDM-105795Drug
TDM-105795 topical solution
PlaceboDrug
Placebo for TDM-105795 topical solution
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohorts 1 -3 TDM-105795 topical solution | Experimental | Single dose administration of TDM-105795 Topical Solution, 0.0025% or 0.005% or 0.01% Receives: Drug: TDM-105795 |
| Placebo for TDM-105795 topical solution | Placebo comparator | Single dose administration of Placebo forTDM-105795 Topical Solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of any local and systemic AEs
Collection of adverse events
Measured: 8 days
Number of subjects with presence (and severity) of local skin reactions (LSRs)
Collection of LSRs
Measured: 8 days
Percent change from Baseline in vital signs
Collection of vital signs on day 1 and day 3
Measured: 3 days
Percent change from Baseline in safety labs
Collection of safety labs at day 2, 3, and 8
Measured: 8 days
Percent change from Baseline in overall interpretation of the ECG
Collection of ECGs at day 1, 3, and 8
Measured: 8 days
Secondary outcomes (1)
Plasma concentrations of TDM-105795
Plasma concentrations of TDM-105795
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start27 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 Following a Fixed-Volume Topical Single Administration in Healthy Male Subjects with Androgenetic Alopecia
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technoderma Medicines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel Piacquadio, M.D., Study director, Therapeutics Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913519
- Sponsor's protocol ID
- 239-11651-101
- Acronym
- AGA
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Dose TDM-105795 Topical Solution in Healthy Male Subjects With AGA
- ClinicalTrials.gov ID
- NCT04913519
- Acronym / sponsor ID
- AGA / 239-11651-101
- Conditions
- Alopecia, Androgenetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technoderma Medicines Inc.Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center, fixed volume, randomized, double-blind, vehicle-controlled, parallel group, dose escalation comparison study of TDM-105795 in male subjects, 18 to 55 years old, with Androgenetic Alopecia (AGA).
Detailed description
Protocol 239-11651-101 is a planned Phase 1 study entitled "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 Following a Fixed-Volume Topical Single Administration 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 onto the scalp in the hair loss area (e.g., top of head and temple areas). All subjects will be treated with 1 mL of test article with application to the scalp focusing on the regions that are bald and thinning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 Following a Fixed-Volume Topical Single Administration in Healthy Male Subjects with Androgenetic Alopecia
| Arm | Type | Receives |
|---|---|---|
| SAD Cohorts 1 -3 TDM-105795 topical solution | Experimental | Drug: TDM-105795Single dose administration of TDM-105795 Topical Solution, 0.0025% or 0.005% or 0.01% |
| Placebo for TDM-105795 topical solution | Placebo comparator | Drug: PlaceboSingle dose administration of Placebo forTDM-105795 Topical Solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- 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 moderate to severe AGA in temple and vertex region, IIIv to VI on the Modified Norwood-Hamilton Scale (i.e., IIIv, IV, V, and VI).
- 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.
- 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.
Key exclusion criteria (16 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 test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
- 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.
- 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 a history of scalp reduction or notable trauma with related scarring, hair transplants, and/or hair weaves.
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-105795TDM-105795 topical solution | Drug | SAD Cohorts 1 -3 TDM-105795 topical solution |
| PlaceboPlacebo for TDM-105795 topical solution | Drug | Placebo for TDM-105795 topical solution |
Primary outcome
Incidence rate of any local and systemic AEs
Time frame: 8 days
Collection of adverse events
Number of subjects with presence (and severity) of local skin reactions (LSRs)
Time frame: 8 days
Collection of LSRs
Percent change from Baseline in vital signs
Time frame: 3 days
Collection of vital signs on day 1 and day 3
Percent change from Baseline in safety labs
Time frame: 8 days
Collection of safety labs at day 2, 3, and 8
Percent change from Baseline in overall interpretation of the ECG
Time frame: 8 days
Collection of ECGs at day 1, 3, and 8
1 secondary outcome
Plasma concentrations of TDM-105795
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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 Piacquadio, M.D. study director
Therapeutics Incorporated
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TDM-105795 in people with Alopecia, Androgenetic, run by Technoderma Medicines Inc. at 2 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 16 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rate of any local and systemic AEs (time frame: 8 days). The study lists 5 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 27 Apr 2022.