AlopeciaPhase 2NCT06692465

To Evaluate the Efficacy and Safety of GT20029 Solution in the Treatment of Androgenetic Alopecia (AGA) in Chinese Adult Males

A Phase 2 study testing GT20029 Tincture in people with Alopecia and Male Pattern Hair Loss, run by Suzhou Kintor Pharmaceutical Inc, at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GT20029 solution. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Alopecia, Male Pattern Hair Loss
What is being tested?: GT20029 Tincture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteChina
Study dates: 13 Apr 2023to 30 Jun 2024
Phase: Phase 2
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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Agree to follow the trial treatment plan and visit plan, voluntarily enroll, and sign the informed consent form in writing.
Male, aged ≥ 18 years old, in good overall health;
Clinical diagnosis of androgenetic alopecia (refer to 2019 edition of Chinese Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia);
Alopecia severity according to Hamilton-Norwood classification IIIv, IV, V;
Willing to maintain the same hair style, hair color and hair length throughout the trial;
No parenting plan and able to use highly effective contraception during the trial and for 3 months after the last dose.

Who cannot join

History of severe systemic diseases/surgical history, which may affect the safety and efficacy evaluation of the investigational drug, such as circulatory system, nervous system, blood system, digestive system (such as inflammatory bowel disease), immune system, mental system diseases;
Alopecia areata or diffuse alopecia areata, syphilis alopecia, cicatricial alopecia, malnutrition, chemotherapy/radiotherapy caused by alopecia;
Patients with scalp skin diseases that affect the efficacy evaluation, trauma in the target area of the scalp or other scalp skin lesions requiring topical drug treatment, such as fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy;
Combined with diseases that have an impact on hair growth, such as connective tissue disease, moderate to severe anemia, and significant weight loss in a short period of time;
Patients who have a history of hair transplantation or need to wear wig hair cover for a long time during the trial treatment;
Combined with endocrine related diseases affecting androgen levels, including but not limited to male testicular disease, Klinefelter syndrome, diseases affecting the hypothalamus-pituitary-gonadal axis;

Show all 21Show fewer

Use of Chinese patent medicine drugs, food and health products with alopecia treatment 1 month before screening, such as Yangxue Shengfa Capsules, Lingdan Tablets, Zhangguang 101 germinal fluid, and Caifei Germinative fluid;
Patients who have taken androgen replacement therapy, immunosuppressive agents, corticosteroids preparations and other drugs that may interfere with the efficacy evaluation within 3 months before screening;
Use of minoxidil within 6 months before screening;
Patients treated with oral finasteride or dutasteride within 12 months before screening;
Patients who have used topical drugs for alopecia sites within 3 months before screening;
Receiving scalp radiation and/or laser or surgical therapy within 3 months before screening;
Use of other medical shampoos or solutions containing ketoconazole or similar ingredients (eg. Terzolin) that may interfere with the efficacy evaluation within 1 month before screening;
Allergic to the investigational drug or known to be allergic to the ingredients of the study product;
Abnormal and clinically significant physical examination, vital signs, 12-lead ECG, blood routine, urine routine, blood biochemistry, sex hormone tests during the screening period, and judged by the investigator to affect the efficacy and safety evaluation of subjects and test results;
Any or more of the results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen or hepatitis C virus antibody are positive;
Participating or participating in ongoing interventional drug or medical device clinical trials within 3 months before screening;
History of drug abuse within 1 year before screening;
Consumption of more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 3 months before screening;
Major surgery within 3 months before screening, or plan to undergo major surgery during the trial;
Other conditions that may affect compliance or unsuitable for participating in this study in the investigator 's opinion.

Trial locations and contacts

1 site in 1 country.

China1 site

Dermatology department, Huashan Hospital, Fudan University
Shanghai

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo -Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GT20029 Solution in the Treatment of Androgenetic Alopecia (AGA) in Chinese Adult Males

The study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GT20029 solution.

Read the detailed description

GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of androgenetic alopecia. A total of 180 adult male subjects with androgenetic alopecia (AGA) (according to Hamilton-Norwood classification IIIv, IV and V) were enrolled in this study. All subjects were randomly assigned in a 1:1:1:1:1:1ratio to investigational drug groups A, B, C and D and placebo groups E and F (i.e., 30 subjects in each group) and treated for 12 weeks at the specified dose and frequency for each group. The primary endpoint of the study is to evaluate the efficacy and safety of GT20029 solution in the treatment of androgenetic alopecia (AGA) in Chinese adult males and to determine the recommended dose for phase III trials.

Conditions: Alopecia, Male Pattern Hair Loss
Being tested: GT20029 Tincture, GT20029 matching placebo
Keywords: Androgenetic Alopecia, Hair loss
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GT20029 TinctureDrug
5mg (0.5%) and 10mg (1%) one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period
GT20029 matching placeboDrug
5mg (0.5%) and 10mg (1%) matching placebo one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) matching placebo twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period

Study groups in NCT06692465
Study group	Role	What they receive
Experimental: GT20029	Experimental	Not described Receives: Drug: GT20029 Tincture
Placebo Comparator: GT20029 Matching Placebo	Placebo comparator	Not described Receives: Drug: GT20029 matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in non-vellus hair count (TAHC, Target Area Hair Counts) within target area (change from baseline at 12 weeks of treatment)
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)
Measured: 12 weeks

Secondary outcomes (4)

Hair growth (HGA) assessment, including subject self-assessment and investigator assessment (change from baseline at 6 and 12 weeks of treatment)
Changes from baseline HGA (Hair Growth Assessment) score by Principal Investigator and subjects (HGA scale ranged from -3 to 3 and represented decreases from baseline that were substantial, moderate, slight, no change, slight increases, moderate increases, and substantial increases, respectively. HGA improvement was defined as a hair growth assessment score of larger than 0.)
Measured: 6 weeks, 12 weeks
TAHC assessment
Change in non-vellus hair count (TAHC) in the target area (change from baseline at 6 weeks of treatment)
Measured: 6 weeks
TAHW assessment
Change in non-vellus hair diameter (TAHW) in the target area (change from baseline at 6 and 12 weeks of treatment)
Measured: 6 weeks, 12 weeks
Terminal hair/vellus hair ratio assessment
Change in terminal hair/vellus hair ratio (change from baseline at 6 and 12 weeks of treatment).
Measured: 6 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 202330 Jun 2024

First posted18 Nov 2024
Study start13 Apr 2023
Primary completion14 Dec 2023
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AlopeciaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06692465
Sponsor's protocol ID: GT20029-CN-1002
Status last verified: Jun 2024
First submitted: 14 Nov 2024
Last updated: 18 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata

All Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo -Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GT20029 Solution in the Treatment of Androgenetic Alopecia (AGA) in Chinese Adult Males
ClinicalTrials.gov ID: NCT06692465
Acronym / sponsor ID: GT20029-CN-1002
Conditions: Alopecia, Male Pattern Hair Loss
Keywords: Androgenetic Alopecia, Hair loss
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
Collaborators: Suzhou Koshine Biomedica, Inc.
Study start: 13 Apr 2023 (actual)
Primary completion: 14 Dec 2023 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 18 Nov 2024 (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.

The study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GT20029 solution.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental: GT20029	Experimental	Drug: GT20029 Tincture
Placebo Comparator: GT20029 Matching Placebo	Placebo comparator	Drug: GT20029 matching placebo

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Agree to follow the trial treatment plan and visit plan, voluntarily enroll, and sign the informed consent form in writing.
Male, aged ≥ 18 years old, in good overall health;
Clinical diagnosis of androgenetic alopecia (refer to 2019 edition of Chinese Guidelines for the Diagnosis and Treatment of Androgenetic Alopecia);
Alopecia severity according to Hamilton-Norwood classification IIIv, IV, V;
Willing to maintain the same hair style, hair color and hair length throughout the trial;

Key exclusion criteria (21 listed)

History of severe systemic diseases/surgical history, which may affect the safety and efficacy evaluation of the investigational drug, such as circulatory system, nervous system, blood system, digestive system (such as inflammatory bowel disease), immune system, mental system diseases;
Alopecia areata or diffuse alopecia areata, syphilis alopecia, cicatricial alopecia, malnutrition, chemotherapy/radiotherapy caused by alopecia;
Patients with scalp skin diseases that affect the efficacy evaluation, trauma in the target area of the scalp or other scalp skin lesions requiring topical drug treatment, such as fungal or bacterial infections, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis or scalp atrophy;
Combined with diseases that have an impact on hair growth, such as connective tissue disease, moderate to severe anemia, and significant weight loss in a short period of time;
Patients who have a history of hair transplantation or need to wear wig hair cover for a long time during the trial treatment;

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
GT20029 Tincture5mg (0.5%) and 10mg (1%) one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period	Drug	Experimental: GT20029
GT20029 matching placebo5mg (0.5%) and 10mg (1%) matching placebo one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) matching placebo twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period	Drug	Placebo Comparator: GT20029 Matching Placebo

Primary outcome

Change in non-vellus hair count (TAHC, Target Area Hair Counts) within target area (change from baseline at 12 weeks of treatment)
Time frame: 12 weeks
Changes from baseline in non-vellus TAHC (Target Area Hair Counts) (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)

4 secondary outcomes

Hair growth (HGA) assessment, including subject self-assessment and investigator assessment (change from baseline at 6 and 12 weeks of treatment)
Time frame: 6 weeks, 12 weeks
TAHC assessment
Time frame: 6 weeks
TAHW assessment
Time frame: 6 weeks, 12 weeks
Terminal hair/vellus hair ratio assessment
Time frame: 6 weeks, 12 weeks

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 18 Nov 2024.
Individual participant dataSharing planned: No

Related trials for Alopecia

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GT20029 Tincture in people with Alopecia and Male Pattern Hair Loss, run by Suzhou Kintor Pharmaceutical Inc, at 1 site in China.

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 6 inclusion and 21 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

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?

Change in non-vellus hair count (TAHC, Target Area Hair Counts) within target area (change from baseline at 12 weeks of treatment) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06692465.

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 18 Nov 2024.