RecruitingPhase 2Phase 3NCT07355075

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)

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


Sponsor

Turn Therapeutics

Enrollment

190 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing GX-03, a topical (applied to the skin) treatment for moderate to severe eczema (atopic dermatitis). Researchers want to see if this product can reduce the severity and extent of eczema flares when applied daily to affected skin areas. **You may be eligible if:** - You are aged 18 to 70 years old - You have moderate to severe eczema confirmed by a doctor using standard assessments - You are generally healthy - You can read, understand, and provide written consent in English - You are willing to apply the study product daily to designated skin areas throughout the study **You may NOT be eligible if:** - You are pregnant, breastfeeding, or planning to become pregnant during the study - You have another skin condition that could interfere with the study assessments - You have used steroid creams, immune-suppressing medications, or anti-inflammatory drugs within the past 3 weeks - You have damaged, sunburned, tattooed, or scarred skin at the test sites - You have used any topical medication at the test site within 72 hours before enrolling - You have a medical condition that, in the investigator's judgment, puts you at risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTGX-03

Topical ointment

OTHERVehicle

Ointment carrier


Locations(1)

ALS Global

Irving, Texas, United States

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NCT07355075


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