Actively Recruiting
A Study to Assess the Efficacy of GX-03 in Moderate to Severe Eczema (Atopic Dermatitis)
Led by Turn Therapeutics · Updated on 2026-01-22
100
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Efficacy of GX-03 in Moderate to Severe Eczema (Atopic Dermatitis)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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-AD12)
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
ALS Global
Irving, Texas, United States, 75062
Actively Recruiting
Research Team
B
Barry Reece, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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