Eczema Atopic Dermatitis study: GX-03 vs Vehicle
Official title 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)
ClinicalTrials.gov ID: NCT07355075
What this study is testing
What is GX-03?
GX-03 is an investigational topical ointment being studied for the treatment of eczema (atopic dermatitis).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if GX‑03 is safe and works for eczema and to learn how well it works and any side effects.
- Who it's for
- Adults who have eczema that is moderate to severe and who feel itchy a lot (pruritus score 7 or higher).
- What's involved
- Participants will apply the ointment or a placebo ointment twice a day for 8 weeks, attend clinic visits for skin checks and give feedback on itching and side effects.
- Time commitment
- The study lasts 8 weeks, with clinic visits at the start, at 4 weeks, and at 8 weeks, plus any additional visits as needed for safety monitoring.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Adults aged 18 to 80 years, inclusive
- Male or female people in good general health as determined by medical history
- Baseline EASI Score of ≥ 1.1
- Baseline vIGA-AD Score of 3 or 4
- Baseline PP-NRS Score of ≥ 7
You likely can't join if
- 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
See the full eligibility criteria
- Adults aged 18 to 80 years, inclusive
- Male or female people in good general health as determined by medical history
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Irving, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irving, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.