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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

GX-03

Topical ointment

OTHER

Vehicle

Ointment carrier

Sponsors & Collaborators

  • Turn Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2026-07-10
Completion
2026-07-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07355075 on ClinicalTrials.gov