GX-03 ointment for adults with moderate to severe eczema
Tests GX-03 ointment against a dummy ointment in adults with eczema.
Plain-language title generated from the registry record
Registry title: A Double-Blind, Randomized, Vehicle-Controlled Phase 2 Study to Assess the Efficacy and Safety of GX-03 in Adult Subjects With Moderate to Severe Atopic Dermatitis (Eczema)
Key facts
- Where
- Irving, United StatesSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07355075, who can take part
Where in United States
- ALS GlobalIrving, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Turn Therapeutics
- Trial code
- NCT07355075
- Record updated
- 4 September 2026
- Original description
This is a Phase 2, two-stage, adaptive, 1:1 randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment in adult subjects with atopic dermatitis (eczema).Read full original descriptionShow less
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 Phase 2, two-stage, adaptive, 1:1 randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment in adult subjects with atopic dermatitis (eczema).
Stage 1 (Completed):
Stage 1 comprised an initial cohort of 50 subjects evaluated through Week 8. Following a pre-specified interim analysis conducted under the supervision of Independent Data Monitoring Committee (IDMC), treatment-response patterns, safety profiles, and endpoint parameters were assessed to optimize enrollment criteria and outcome measures for Stage 2.
Stage 2 (Active/Recruiting):
Stage 2 plans to enroll approximately 135 subjects across three baseline EASI severity strata (1.1 to 7.0, 7.1 to 15.9, and 16.0 and above) with a target of at least 120 subjects completing the 8-week treatment period. Enrollment for Stage 2 is specifically enriched for subjects presenting with significant pruritus (baseline Peak Pruritus Numeric Rating Scale [PP-NRS] of 7 or more) and baseline EASI of 1.1 or more.
Exclusion: 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; Presence of any skin condition or dermatologic disease that could interfere with study treatment or assessments; Any medical condition that, in the investigator's judgment, places the subject at undue risk or compromises study integrity; Individuals meeting any of the following criteria will be excluded:; Pregnant, breastfeeding, or planning pregnancy during the study; Damaged or altered skin at or near test sites (e.g., sunburn, tattoos, scars, uneven pigmentation) that could confound evaluations.
Participants must meet all of the following criteria:; Adults aged 18 to 80 years, inclusive; Male or female subjects in good general health as determined by medical history; Subjects meeting all of the following baseline criteria:; Baseline EASI Score of ≥ 1.1; Baseline vIGA-AD Score of 3 or 4; Baseline PP-NRS Score of ≥ 7; Ability to read, understand, and provide written informed consent in English; 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.