100 Participants Needed

GX-03 for Eczema

(GX-03 in AD Trial)

BR
Overseen ByBarry Reece, MS
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called GX-03, a cream for individuals with moderate to severe eczema. Researchers aim to determine if GX-03 is safe and effective compared to a regular moisturizer. Participants will use either GX-03 or a placebo (a look-alike cream without the active ingredient) for eight weeks. Individuals with noticeable eczema that impacts their daily life may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you cannot use systemic or topical immunosuppressive therapies, including corticosteroids, within 3 weeks before starting, and you should not use anti-inflammatory medications or topical medications at the test sites shortly before enrollment.

Is there any evidence suggesting that GX-03 is likely to be safe for humans?

Research shows that GX-03 is generally safe. The FDA has approved this skin treatment for other uses, indicating it is usually well-tolerated. Previous studies reported no major side effects for GX-03 in these other uses, providing some confidence about its safety for people with eczema. However, this study specifically examines its safety for eczema. Researchers will monitor participants for any side effects during the trial.12345

Why do researchers think this study treatment might be promising?

Most treatments for eczema, like topical corticosteroids or calcineurin inhibitors, work by reducing inflammation and suppressing the immune response. But GX-03 is different because it targets a novel pathway involved in the skin's immune response, potentially offering a new approach to managing eczema. Researchers are excited about GX-03 because it might provide relief with fewer side effects compared to current options, making it a promising alternative for patients who struggle with standard treatments.

What evidence suggests that GX-03 might be an effective treatment for eczema?

Research shows that GX-03, which participants in this trial may receive, may help treat eczema. In earlier studies, people using GX-03 had an average skin condition score of 0.83, while those using a placebo scored 2.44. This improvement mirrors results seen with some advanced drugs. Lab tests showed that GX-03 reduced disease severity by over 50% compared to a placebo. These findings suggest that GX-03 could effectively relieve symptoms of moderate to severe eczema.12356

Are You a Good Fit for This Trial?

Adults aged 18-70 with moderate to severe eczema can join this study. They must be in good health, able to understand English, and willing to follow the study's rules like using only the assigned product on affected areas for 8 weeks.

Inclusion Criteria

I am in good health overall.
Agreement to use only the assigned study product on designated areas of interest for the duration of the study
Ability to read, understand, and provide written informed consent in English
See 3 more

Exclusion Criteria

Pregnant, breastfeeding, or planning pregnancy during the study
Any medical condition that, in the investigator's judgment, places the subject at undue risk or compromises study integrity
I don't have damaged or altered skin where they will test.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GX-03 or a vehicle control, applied topically to affected areas at least twice daily for 8 weeks

8 weeks
3 visits (in-person), weekly telephone check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GX-03

Trial Overview

The trial is testing GX-03, a new cream for eczema against a petrolatum-based control (like Vaseline). Participants are randomly chosen to use one of these treatments for two months while doctors track their skin's improvement using specific scoring systems.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: GX-03Experimental Treatment1 Intervention
Group II: VehiclePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Turn Therapeutics

Lead Sponsor

Trials
1
Recruited
90+

Citations

A Study to Assess the Efficacy of GX-03 in Moderate ...

Efficacy will be assessed using validated clinical outcome measures, including the Eczema Area and Severity Index (EASI), the Validated ...

Atopic Dermatitis Drug Candidate Significantly Inhibits Key ...

ISGA mean score of 0.83 with GX-03 topical pre-treatment vs 2.44 placebo, comparable to biologics; Company projects phase 1b/2 efficacy trials ...

Turn Therapeutics Launches Trial for AD Topical GX-03

Turn Therapeutics announced the commencement of a randomized, double-blind, vehicle-controlled clinical trial evaluating its topical GX-03 formation.

Turn Therapeutics Launches First Clinical Trial to Assess ...

GX-03 has proven effective in preclinical trials, reducing disease severity by more than 50% vs placebo. Data from the current study are ...

GX-03 for Eczema (GX-03 in AD Trial)

This is a randomized, double-blind, vehicle-controlled clinical study designed to evaluate the efficacy and safety of GX-03, ...

5 Novel Mechanisms Reshaping Atopic Dermatitis ...

Long-term safety data ... Clinical Evidence: Turn Therapeutics launched its first clinical trial to assess GX-03 in atopic dermatitis in July this ...