NCT07355075 A Study to Assess the Efficacy of GX-03 in Moderate to Severe Eczema (Atopic Dermatitis)
| NCT ID | NCT07355075 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Turn Therapeutics |
| Condition | Eczema Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-05-31 |
Trial Parameters
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Brief Summary
This is a randomized, double-blind, vehicle-controlled clinical study designed to evaluate the efficacy and safety of GX-03, a topically applied emollient, in adult subjects with moderate to severe eczema. Approximately 120 adult participants will be enrolled and randomized in a 1:1 ratio to receive either GX-03 or a petrolatum-based vehicle control for 8 consecutive weeks. Efficacy will be assessed using validated clinical outcome measures, including the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), and the Peak Pruritus Numeric Rating Scale (PP-NRS). Safety will be evaluated through monitoring of treatment-emergent adverse events throughout the study period.
Eligibility Criteria
Participants must meet all of the following criteria: * Adults aged 18 to 70 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) and * 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 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 syste
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