A Study to Assess the Efficacy of GX-03 in Moderate to Severe Eczema (Atopic Dermatitis)
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
100 participants
Jul 11, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria8
- 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 systemic or topical immunosuppressive therapies, including corticosteroids, within 3 weeks prior to enrollment
- Use of anti-inflammatory medications (e.g., topical steroids, ibuprofen, celecoxib); steroid nasal or ophthalmic drops are permitted
- Use of topical medications at the test sites within 72 hours prior to enrollment
- Damaged or altered skin at or near test sites (e.g., sunburn, tattoos, scars, uneven pigmentation) that could confound evaluations
- Any medical condition that, in the investigator's judgment, places the subject at undue risk or compromises study integrity
Interventions
Topical petrolatum-based ointment
Ointment carrier
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07355075