Turn Therapeutics
This is a Phase 2, two-stage, adaptive, 1:1 randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment in adult subjects with atopic dermatitis (eczema). Stage 1 (Completed): Stage 1 comprised an initial cohort of 50 subjects evaluated through Week 8. Following a pre-specified interim analysis conducted under the supervision of Independent Data Monitoring Committee (IDMC), treatment-response patterns, safety profiles, and endpoint parameters were assessed to optimize enrollment criteria and outcome measures for Stage 2. Stage 2 (Active/Recruiting): Stage 2 plans to enroll approximately 135 subjects across three baseline EASI severity strata (1.1 to 7.0, 7.1 to 15.9, and 16.0 and above) with a target of at least 120 subjects completing the 8-week treatment period. Enrollment for Stage 2 is specifically enriched for subjects presenting with significant pruritus (baseline Peak Pruritus Numeric Rating Scale \[PP-NRS\] of 7 or more) and baseline EASI of 1.1 or more.
This is a Phase 2, adaptive, randomized, double-blind, vehicle-controlled study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment (a non-systemic formulation containing polyhexanide) compared with matching vehicle control in adult participants with atopic dermatitis (AD). Stage 1 (Completed): Stage 1 enrolled 50 participants (53 subjects randomized, 50 completed) using broad severity eligibility criteria (baseline EASI \>7 or vIGA-AD 3 or 4) to evaluate treatment behavior and biomarker concordance across a wide spectrum of AD phenotypes. Following completion of the…
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 * Subjects meeting all of the following baseline criteria: * Baseline EASI Score of ≥ 1.1 * Baseline vIGA-AD Score of 3 or 4 * Baseline PP-NRS Score of ≥ 7 * Ability to read, understand, and provide written informed consent in English * 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 ap…
Topical ointment
Ointment carrier
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