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
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.
⁃ 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