NCT07355075 · Turn Therapeutics
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)
(GX-03 in AD)
What this study is about
This is a Phase 2, randomly assigned, where neither patients nor doctors know which treatment is given, vehicle-controlled clinical study evaluating the effectiveness and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema).
View original scientific description
This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and an ability to expand enrollment up to 200 subjects based on a pre-specified interim assessment conducted by an Independent Data Monitoring Committee (IDMC). Subjects will be randomized in a 1:1 ratio to receive either GX-03 or vehicle control for 8 weeks. The study is designed to evaluate improvement in investigator-assessed disease severity, itch, and patient-reported eczema symptoms following topical treatment with GX-03 compared with vehicle control. Efficacy assessments include the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), Eczema Area and Severity Index (EASI), Peak Pruritus Numeric Rating Scale (PP-NRS), and Patient-Oriented Eczema Measure (POEM). An interim assessment of conditional power for the primary efficacy endpoint will occur after the first 50 subjects complete the Week 8 visit or withdraw prematurely. Based on pre-specified criteria defined in the IDMC Charter, the IDMC may recommend continuation as planned, expansion of enrollment up to 200 subjects, or early curtailment of enrollment.
Interventions
COMBINATION_PRODUCT
GX-03
Topical ointment
OTHER
Vehicle
Ointment carrier
Primary outcome measures
Change in Investigator Global Assessment (IGA) at Week 8
Time frame: At Day 56 (Week 8)
vIGA-AD score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 8
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Presence of visible eczematous skin with disease severity consistent with moderate to severe eczema, as assessed by:
- Eczema Area and Severity Index (EASI) or 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
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
- Irving, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations