A Double-Blind, Vehicle-Controlled Study to Assess the Efficacy of GX-03 When Used in a Population of Adult Individuals With Moderate to Severe Eczema
Turn Therapeutics
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.
Description
This Phase 2, randomized, double-blind, vehicle-controlled study will assess the efficacy and safety of GX-03 in adult individuals aged 18 to 70 years with moderate to severe eczema. Eligible participants will be randomly assigned to receive either GX-03 or a vehicle control, applied topically to affected areas at least twice daily for 8 weeks. The investigational product and vehicle will be identical in appearance and packaging to maintain blinding. Clinical efficacy will be evaluated at baseline and at Weeks 4 and 8. The primary efficacy endpoint is the change from baseline in Eczema Area a…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 appli…
Interventions
- Combination ProductGX-03
Topical petrolatum-based ointment
- OtherVehicle
Ointment carrier
Location
- ALS GlobalIrving, Texas