Completed

GT20029 Solution for Androgenetic Alopecia in Chinese Men

What is being tested

GT20029 Tincture

+ GT20029 matching placebo

Drug

Who is being recruted

Alopecia+4

+ Hair Diseases

+ Hypotrichosis

Over 18 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: April 2023

See protocol details

Summary

Principal SponsorSuzhou Kintor Pharmaceutical Inc,

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 13, 2023

Actual date on which the first participant was enrolled.

This study focuses on testing a new treatment called GT20029 for male pattern baldness, which is a common type of hair loss in men. The study enrolls 180 Chinese adult males who have this condition, categorized as stages IIIv, IV, and V according to a specific classification system. The aim is to see how well GT20029 works and how safe it is for treating this type of hair loss. By finding the right dose, the study hopes to provide a new treatment option that could help men dealing with hair loss. Participants in the study receive either the GT20029 solution or a placebo, with the treatment applied over a span of 12 weeks. They are divided into six groups, with each group receiving different dosages or the placebo. The study measures the effectiveness and safety of the treatment by observing changes in hair growth and checking for any side effects. This helps determine the best dose for future trials, ensuring both effectiveness and safety for those who might use the treatment in the future.

Official TitleA 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

NCT06692465

Principal SponsorSuzhou Kintor Pharmaceutical Inc,

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlopeciaHair DiseasesHypotrichosisSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesPathological Conditions, Anatomical

Criteria

6 inclusion criteria required to participate

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;

Show More Criteria

21 exclusion criteria prevent from participating

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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Dermatology department, Huashan Hospital, Fudan University

Shanghai, ChinaOpen Dermatology department, Huashan Hospital, Fudan University in Google Maps

CompletedOne Study Center