Recruiting
Phase 2
Phase 3

GX-03

Sponsor:

Turn Therapeutics

Code:

NCT07355075

Conditions

Eczema Atopic Dermatitis

Eczema

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

GX-03

Vehicle

Study Details

Brief 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.

Conditions

Eczema Atopic Dermatitis

Eczema

Atopic Dermatitis

Study ID

NCT07355075

Start date

Jul 11, 2025

Status verified date

Sep, 2026

Completion date

Jan 20, 2027

Anticipated

Primary completion date

Jan 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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
  • Subjects meeting all of the following baseline criteria:

  • Baseline EASI Score of ≥ 1.1
  • Baseline vIGA-AD Score of 3 or 4
  • Baseline PP-NRS Score of ≥ 7
  • Ability to read, understand, and provide written informed consent in English
  • 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

Study Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GX-03

Treatment Arm

experimental: Vehicle

Vehicle Control

Interventions

GX-03

Topical ointment

Vehicle

Ointment carrier

Primary outcome measure

  • vIGA-AD Success at Week 4 [ Time Frame: At Day 28 (Week 4) ]
  • EASI-75 at Week 4 [ Time Frame: At Day 28 (Week 4) ]
  • EASI-90 at Week 8 [ Time Frame: At Day 56 (Week 8) ]
  • EASI-100 at Week 8 [ Time Frame: At Day 56 (Week 8) ]

Central Contacts and Locations

Central contacts

Barry Reece, MS

9728714371barry.reece@alsglobal.com

Locations

ALS Global

Recruiting

Irving, Texas, United States, 75062

Contacts

Jordan Williams

9725732908jordan.williams@alsglobal.com

More Information

Sponsor

Turn Therapeutics

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Moderate-Severe AD
  • Moderate-Severe Eczema
  • Eczema
  • Atopic Dermatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Turn Therapeutics on 2026-09-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.