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Tests treatment safety and results for Eczema Atopic Dermatitis
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 medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for 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
- This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and an ability to expand enrollment up to 200 subjects based on a pre-specified interim assessment conducted by an Independent Data Monitoring Committee (IDMC).
- Phase 2: a mid-size study of how well it works
- 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
- Participants must meet all of the following criteria:
- Adults aged 18 to 80 years, inclusive
- Male or female people in good general health as determined by medical history
- Presence of visible eczematous skin with disease severity consistent with moderate to severe eczema, as assessed by:
- Eczema Area and Severity Index (EASI) or Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™)
You likely can't join 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
See the full eligibility criteria
- Participants must meet all of the following criteria:
- Adults aged 18 to 80 years, inclusive
- Male or female people in good general health as determined by medical history
- Presence of visible eczematous skin with disease severity consistent with moderate to severe eczema, as assessed by:
- Eczema Area and Severity Index (EASI) or Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™)
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Irving, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.