A Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Sa
This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and a
| Condition(s) | Eczema Atopic Dermatitis, Eczema, Atopic Dermatitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and an ability to expand enrollment up to 200 subjects based on a pre-specified interim assessment conducted by an Independent Data Monitoring Committee (IDMC). Subjects will be randomized in a 1:1 ratio to receive either GX-03 or vehicle control for 8 weeks. The study is designed to evaluate improvement in investigator-assessed disease severity, itch, and patient-reported eczema symptoms following topical treatment with GX-03 compared with vehicle control. Efficacy assessments in |
| Who can participate | Participants must meet all of the following criteria: * Adults aged 18 to 80 years, inclusive * Male or female subjects in good general health as determined by medical history * Presence of visible eczematous skin with disease severity consistent with moderate to severe eczema, as assessed by: * Eczema Area and Severity Index (EASI) or Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) * Ability to read, understand, and provide written informed consent in English * Willingness and ability to comply with study procedures, including study visits and daily topical application * Agreement to use only the assigned study product on designated areas of interest for the duration of the study Exclusion Criteria Individuals meeting any of the following criteria will be exclude |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Turn Therapeutics |
| Locations | Irving, Texas, United States |
| Start date | 2025-07-11 |
| NCT ID | NCT07355075 |
| Official listing | https://clinicaltrials.gov/study/NCT07355075 |