GX-03 topical treatment for adults with moderate to severe eczema
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 study will test whether applying GX-03, a topical emollient, twice daily for 8 weeks reduces eczema severity and itch in adults with moderate to severe atopic dermatitis compared with a petrolatum-based vehicle.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Turn Therapeutics Industry-sponsored |
| Locations | 1 site (Irving, Texas) |
| Trial ID | NCT07355075 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2, randomized, double-blind, vehicle-controlled study enrolling about 120 adults aged 18–70 with moderate to severe atopic dermatitis. Participants will be randomized 1:1 to receive either GX-03 or a petrolatum-based vehicle, applied topically at least twice daily for 8 weeks, with the investigational product and vehicle identically packaged to maintain blinding. Efficacy will be measured at baseline, Week 4, and Week 8 using EASI, vIGA-AD™, and Peak Pruritus NRS, with additional patient-reported outcomes collected as exploratory measures. Safety monitoring includes collection of treatment-emergent adverse events, weekly telephone check-ins during interim weeks, and on-site safety assessments at study visits.
Who should consider this trial
Good fit: Adults aged 18 to 70 with visible moderate to severe atopic dermatitis (per EASI and vIGA-AD™), able to read English, give informed consent, and apply the assigned topical product as directed are ideal candidates.
Not a fit: People with only mild eczema, active dermatologic conditions that would interfere with assessments, pregnant or breastfeeding individuals, or those unable to comply with topical treatment and clinic visits are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, GX-03 could reduce skin inflammation and itching and improve comfort and quality of life for adults with moderate to severe eczema using a topical, low-systemic-risk option.
How similar studies have performed: Other topical emollients and topical therapies have shown symptom improvement in prior studies, but GX-03's specific formulation is novel and has not yet been proven in Phase 2 testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Criteria 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
Where this trial is running
Irving, Texas
- ALS Global — Irving, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Barry Reece, MS
- Email: barry.reece@alsglobal.com
- Phone: 9728714371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.