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)

NCT07355075 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: Protocol/Panel 4604
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis; Eczema; Eczema Atopic Dermatitis

Keywords

Moderate-Severe AD; Moderate-Severe Eczema; Eczema; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change in Investigator Global Assessment (IGA) at Week 8

  vIGA-AD score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 8

  At Day 56 (Week 8)

Secondary Outcomes (3)

• Change in Baseline Eczema Area and Severity (EASI) at Week 8

  At Day 56 (Week 8)

• ≥4 Point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 8

  At Day 56 (Week 8)

• Patient-Oriented Eczema Measure (POEM) score at Week 8

  At Day 56 (Week 8)

Other Outcomes (5)

• Change from baseline in Validated Investigator Global Assessment (vIGA-AD) at Week 4

  At Day 28 (Week 4)

• Change from Baseline in Eczema Area Severity Index (EASI) at Week 4

  At Day 28 (Week 4)

• ≥4 Point reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 4

  At Day 28 (Week 4)

Study Arms (2)

GX-03

EXPERIMENTAL

Treatment Arm

Combination Product: GX-03

Vehicle

EXPERIMENTAL

Vehicle Control

Other: Vehicle

Interventions

GX-03 COMBINATION_PRODUCT

Topical ointment

GX-03

Vehicle OTHER

Ointment carrier

Vehicle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Turn Therapeutics: lead

Study Sites (1)

ALS Global

Irving, Texas, 75062, United States

RECRUITING

Related Links

• Sponsor Website

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Barry Reece, MS

CONTACT

9728714371; barry.reece@alsglobal.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded, vehicle controlled, randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The test article will be distributed to study participants and each participant instructed to use the test article on an area of interest. Each subject will be evaluated using the EASI severity scale, vIGA-AD™ scoring system, and PP-NRS score. Evaluations will occur at baseline and again after 4 and 8 weeks of daily use.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 21, 2026
• Study Start: July 11, 2025
• Primary Completion: July 10, 2026
• Study Completion: July 10, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)