A Study to Assess the Efficacy of GX-03 in Moderate to Severe Eczema (Atopic Dermatitis)

NCT07355075 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: Protocol/Panel 4604
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, vehicle-controlled clinical study designed to evaluate the efficacy and safety of GX-03, a topically applied emollient, in adult subjects with moderate to severe eczema. Approximately 120 adult participants will be enrolled and randomized in a 1:1 ratio to receive either GX-03 or a petrolatum-based vehicle control for 8 consecutive weeks. Efficacy will be assessed using validated clinical outcome measures, including the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), and the Peak Pruritus Numeric Rating Scale (PP-NRS). Safety will be evaluated through monitoring of treatment-emergent adverse events throughout the study period.

Conditions

Eczema Atopic Dermatitis; Eczema; Atopic Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Eczema Area and Severity (EASI)

  Change in EASI Over 4 and 8 Weeks

  Four and Eight Weeks

Secondary Outcomes (2)

• Change in Investigator Global Assessment (IGA)

  Four and Eight Weeks

• Change in NRS Max Itch

  Four and Eight Weeks

Study Arms (2)

GX-03

EXPERIMENTAL

Treatment Arm

Combination Product: GX-03

Vehicle

PLACEBO COMPARATOR

Vehicle Control

Other: Vehicle

Interventions

GX-03 COMBINATION_PRODUCT

Topical petrolatum-based ointment

GX-03

Vehicle OTHER

Ointment carrier

Vehicle

Eligibility Criteria

• Age: 18 Years - 70 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 (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)