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

NCT06692465 | Completed Phase 2

• 1 other identifier: GT20029-CN-1002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia; Male Pattern Hair Loss

Keywords

Androgenetic Alopecia; Hair loss

Outcome Measures

Primary Outcomes (1)

• 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.)

  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)

  6 weeks, 12 weeks

• TAHC assessment

  6 weeks

• TAHW assessment

  6 weeks, 12 weeks

• Terminal hair/vellus hair ratio assessment

  6 weeks, 12 weeks

Study Arms (2)

Experimental: GT20029

EXPERIMENTAL

Drug: GT20029 Tincture

Placebo Comparator: GT20029 Matching Placebo

PLACEBO COMPARATOR

Drug: GT20029 matching placebo

Interventions

GT20029 Tincture DRUG

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

Experimental: GT20029

GT20029 matching placebo DRUG

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

Placebo Comparator: GT20029 Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead
• Suzhou Koshine Biomedica, Inc.: collaborator

Study Sites (1)

Dermatology department, Huashan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: April 13, 2023
• Primary Completion: December 14, 2023
• Study Completion: June 30, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)