A Study to Assess the Efficacy of GX-03 in Moderate to Severe Eczema (Atopic Dermatitis)
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.
detailed 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 and Severity Index (EASI) score at Weeks 4 and 8. Secondary efficacy endpoints include changes from baseline in vIGA-AD™ scores and Peak Pruritus Numeric Rating Scale (PP-NRS) scores at the same time points. Subject-reported outcomes and product preference questionnaires will also be collected as exploratory measures.
Safety assessments will include the collection of spontaneous and solicited adverse events from the first application through the final study visit. Weekly telephone safety check-ins will be conducted during interim weeks, and adverse events will be assessed at all on-site visits. The study is expected to enroll sufficient subjects to ensure that at least 100 participants complete the full 8-week treatment period.
official title
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