GT20029 Gel for Acne

No longer recruiting at 1 trial location

Overseen By Clinical Operations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Suzhou Kintor Pharmaceutical Inc,

Must not be taking: Androgen agents, Retinoids

Disqualifiers: Malignancy, HIV, Hepatitis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gel treatment called GT20029 Gel to evaluate its safety and how the body processes it. The focus is on individuals with androgenetic alopecia (a common form of hair loss) and acne. Participants will receive either the actual gel or a placebo, a gel without active ingredients, to compare results. Those with mild to moderate hair loss or acne who can maintain their usual grooming routines might be a good fit for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking any prescription or over-the-counter medications, as well as herbal supplements, at least 14 days before the trial starts. However, you can use acetaminophen in small amounts until 24 hours before the trial.

Is there any evidence suggesting that GT20029 Gel is likely to be safe for humans?

Research has shown that GT20029 gel is generally safe based on previous studies. It does not spread much throughout the body, which indicates good safety. Users of the gel reported few negative side effects, suggesting it was well-tolerated. Another study found that the gel was safe and caused few unwanted effects. Overall, these findings suggest that GT20029 gel is safe for human use so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about GT20029 because it represents a new approach to treatment with its topical gel formulation, which may offer a more targeted delivery method compared to oral or systemic treatments. This experimental treatment is being studied for its safety, tolerability, and how it behaves in the body, which could potentially lead to fewer side effects than existing options. Unlike traditional treatments that might involve invasive procedures or systemic medication, GT20029's localized application could make it a convenient and less intrusive option for patients.

What evidence suggests that GT20029 Gel might be an effective treatment for androgenetic alopecia or acne?

Research has shown that GT20029 gel, which participants in this trial may receive, could help treat hair loss and acne. Studies have found that GT20029 promotes hair growth and reduces the activity of oil-producing glands in the skin. Previous users found it safe and easy to tolerate, with few side effects. The gel works by breaking down certain receptors in the body involved in these conditions. This suggests that GT20029 could become an important new treatment for those dealing with hair loss and acne. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;

Subjects with a weight of ≥ 50 kg for male, a weight of ≥ 45 kg for female, and a body mass index (BMI) between 19 and 30 kg/m2 (inclusive);

You understand and agree to comply with the study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical single and multiple ascending doses of GT20029 or placebo

8 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GT20029 Gel
• GT20029 Gel Placebo

How Is the Trial Designed?

Group I: GT20029 Experimental Treatment 1 Intervention

Group II: GT20029 Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Suzhou Kintor Pharmaceutical Inc,

Lead Sponsor

Trials

18

Recruited

3,900+

Citations

1. en.kintor.com.cn en.kintor.com.cn/news_details/17.html

Phase II Clinical Trial Of GT20029 Gel For The Treatment ... In terms of safety, GT20029 gel exhibited satisfactory safety and tolerability in the clinical trial, with a low incidence of overall adverse ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05428449

NCT05428449 | Study in Subjects to Evaluate the Safety ... A randomized, double-blind, placebo-controlled, parallel group, dose escalation study to evaluate the safety, tolerability and pharmacokinetics (PK) of GT20029.

3. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress2023/33477.pdf

750 Safety, Tolerability and Pharmacokinetics of GT20029 ... Therefore, it showed potential treatment efficacy in promoting hair growth and inhibiting sebaceous gland development. GT20029 also exhibited low systemic ...

4. ctv.veeva.com ctv.veeva.com/study/to-evaluate-the-safety-tolerability-and-pk-of-gt20029-gel-and-solution-in-healthy-subjects

To Evaluate the Safety, Tolerability and PK of GT20029 Gel ... GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of acne and androgenetic alopecia.

5. hairly.app hairly.app/blog/gt20029-a-potential-breakthrough-treatment-for-androgenic-alopecia

GT20029: A Potential Breakthrough Treatment for ... These trials were completed in August 2022 and the results showed that GT20029 was safe and tolerable for androgenic alopecia. The application site's redness, ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=2c89f8bf-ea6d-4880-95d2-a3d075cbe445

GT20029 / Kintor Pharma - Alopecia • Dermatology Safety, Tolerability and Pharmacokinetics of GT20029 Gel and GT20029 Solution in Healthy Subjects (EADV 2023) - "Overall, HVs who received a single ...