GX-03 topical treatment for adults with moderate to severe eczema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, double-blind, vehicle-controlled study enrolling about 120 adults aged 18–70 with moderate to severe atopic dermatitis. Participants will be randomized 1:1 to receive either GX-03 or a petrolatum-based vehicle, applied topically at least twice daily for 8 weeks, with the investigational product and vehicle identically packaged to maintain blinding. Efficacy will be measured at baseline, Week 4, and Week 8 using EASI, vIGA-AD™, and Peak Pruritus NRS, with additional patient-reported outcomes collected as exploratory measures. Safety monitoring includes collection of treatment-emergent adverse events, weekly telephone check-ins during interim weeks, and on-site safety assessments at study visits.

Why it matters

Who can join: the full rules

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

Where it's running

• ALS Global
  Irving, Texas, United States Recruiting

Study contacts

• Study coordinator: Barry Reece, MS
• Email: barry.reece@alsglobal.com
• Phone: 9728714371

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• IMG-007 for adults with moderate-to-severe atopic dermatitis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.