A Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Safety of GX-03 in Adult Subjects With Moderate to Severe Atopic Dermatitis (Eczema)
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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 include the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), Eczema Area and Severity Index (EASI), Peak Pruritus Numeric Rating Scale (PP-NRS), and Patient-Oriented Eczema Measure (POEM). An interim assessment of conditional power for the primary efficacy endpoint will occur after the first 50 subjects complete the Week 8 visit or withdraw prematurely. Based on pre-specified criteria defined in the IDMC Charter, the IDMC may recommend continuation as planned, expansion of enrollment up to 200 subjects, or early curtailment of enrollment.
Sponsor: Turn Therapeutics
You may not qualify if…
- ✕ Individuals meeting any of the following criteria will be excluded:
- ✕ Pregnant, breastfeeding, or planning pregnancy during the study
- ✕ Presence of any skin condition or dermatologic disease that could interfere with study treatment or assessments
- ✕ Use of systemic or topical immunosuppressive therapies, including corticosteroids, within 3 weeks prior to enrollment
- ✕ Use of anti-inflammatory medications (e.g., topical steroids, ibuprofen, celecoxib); steroid nasal or ophthalmic drops are permitted
- ✕ Use of topical medications at the test sites within 72 hours prior to enrollment
- ✕ Damaged or altered skin at or near test sites (e.g., sunburn, tattoos, scars, uneven pigmentation) that could confound evaluations
- ✕ Any medical condition that, in the investigator's judgment, places the subject at undue risk or compromises study integrity
Where it's recruiting
Irving
Source: ClinicalTrials.gov · NCT07355075 · last updated 2026-05-18