Eczema Atopic DermatitisPhase 2/3GX-03 in ADNCT07355075
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)
A Phase 2/3 study testing GX-03 in people with Eczema Atopic Dermatitis and Eczema, run by Turn Therapeutics at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eczema Atopic Dermatitis, Eczema, Atopic Dermatitis
- What is being tested?
- GX-03
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 20 Jan 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ALS Global
Irving, Texas, 75062
Jordan Williams, 9725732908, jordan.williams@alsglobal.com
About this study
Official title: A Double-Blind, Vehicle-Controlled Study to Assess the Efficacy of GX-03 When Used in a Population of Adult Individuals With Moderate to Severe Eczema
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):
Read more
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.
Read the detailed description
This is a Phase 2, adaptive, randomized, double-blind, vehicle-controlled study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment (a non-systemic formulation containing polyhexanide) compared with matching vehicle control in adult participants with atopic dermatitis (AD).
Stage 1 (Completed):
Stage 1 enrolled 50 participants (53 subjects randomized, 50 completed) using broad severity eligibility criteria (baseline EASI >7 or vIGA-AD 3 or 4) to evaluate treatment behavior and biomarker concordance across a wide spectrum of AD phenotypes. Following completion of the 8-week evaluation period in 50 participants, an unblinded interim review was conducted by an Independent Data Monitoring Committee (IDMC).
Stage 2 (Active / Recruiting):
Guided by Stage 1 findings, Stage 2 prospectively evaluates GX-03 in an expanded cohort of approximately 135 participants (target: 120 completing the study). Stage 2 enrollment is stratified across three baseline EASI severity bands (1.1-7.0, 7.1-15.9, and 16.0 or above) and enriched for participants with severe baseline PP-NRS of 7 or above).
In both stages, eligible participants are randomized in a 1:1 ratio to receive topically applied GX-03 or matching vehicle control self-administered to affected skin areas at least twice daily for 8 consecutive weeks.
Efficacy assessments are conducted at Week 4, and Week 8 using a superiority testing framework. To control the overall Type I error rate across multiple primary and key secondary endpoints in Stage 2, a Hochberg multiplicity adjustment procedure will be applied. Evaluated endpoints include:
- Week 4 vIGA-AD Success (vIGA-AD Success defined as a score of 0 or 1 with at least 2 grade improvement).
- Week 4 EASI-75 (EASI-75 defined as at least a 75% reduction in Eczema Area Severity Index)
- Week 8 EASI-90 (EASI-90 defined as at least a 90% reduction in Eczema Area Severity Index)
- Week 8 EASI-100 (EASI-100 defined as 100% reduction in Eczema Area Severity Index)
Safety Monitoring:
Safety assessments include treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), local site tolerability monitoring, and concomitant medication reviews across the treatment and follow-up periods.
- Conditions
- Eczema Atopic Dermatitis, Eczema, Atopic Dermatitis
- Being tested
- GX-03, Vehicle
- Keywords
- Moderate-Severe AD, Moderate-Severe Eczema, Eczema, Atopic Dermatitis
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-03Combination product
Topical ointment
VehicleOther
Ointment carrier
| Study group | Role | What they receive |
|---|---|---|
| GX-03 | Experimental | Treatment Arm Receives: Combination Product: GX-03 |
| Vehicle | Experimental | Vehicle Control Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
vIGA-AD Success at Week 4
vIGA-AD Success defined as score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 4.
All Primary Outcome measures will be evaluated using the Hochberg-method.
Measured: At Day 28 (Week 4)
EASI-75 at Week 4
75% reduction from baseline in Eczema Area Severity Index (EASI) at Week 4.
All Primary Outcome measures will be evaluated using the Hochberg-method.
Measured: At Day 28 (Week 4)
EASI-90 at Week 8
90% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8.
All Primary Outcome measures will be evaluated using the Hochberg-method.
Measured: At Day 56 (Week 8)
EASI-100 at Week 8
100% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8.
All Primary Outcome measures will be evaluated using the Hochberg-method.
Measured: At Day 56 (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start11 Jul 2025
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eczema Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turn Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355075
- Sponsor's protocol ID
- Protocol/Panel 4604
- Acronym
- GX-03 in AD
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Protection of participant privacy and re-identification risks Ongoing regulatory or commercial activities Intellectual property and competitive concerns Resource and practical barriers
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Vehicle-Controlled Study to Assess the Efficacy of GX-03 When Used in a Population of Adult Individuals With Moderate to Severe Eczema
- ClinicalTrials.gov ID
- NCT07355075
- Acronym / sponsor ID
- GX-03 in AD / Protocol/Panel 4604
- Conditions
- Eczema Atopic Dermatitis, Eczema, Atopic Dermatitis
- Keywords
- Moderate-Severe AD, Moderate-Severe Eczema, Eczema, Atopic Dermatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Turn TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2, adaptive, randomized, double-blind, vehicle-controlled study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment (a non-systemic formulation containing polyhexanide) compared with matching vehicle control in adult participants with atopic dermatitis (AD).
Stage 1 (Completed):
Stage 1 enrolled 50 participants (53 subjects randomized, 50 completed) using broad severity eligibility criteria (baseline EASI >7 or vIGA-AD 3 or 4) to evaluate treatment behavior and biomarker concordance across a wide spectrum of AD phenotypes. Following completion of the 8-week evaluation period in 50 participants, an unblinded interim review was conducted by an Independent Data Monitoring Committee (IDMC).
Stage 2 (Active / Recruiting):
Guided by Stage 1 findings, Stage 2 prospectively evaluates GX-03 in an expanded cohort of approximately 135 participants (target: 120 completing the study). Stage 2 enrollment is stratified across three baseline EASI severity bands (1.1-7.0, 7.1-15.9, and 16.0 or above) and enriched for participants with severe baseline PP-NRS of 7 or above).
In both stages, eligible participants are randomized in a 1:1 ratio to receive topically applied GX-03 or matching vehicle control self-administered to affected skin areas at least twice daily for 8 consecutive weeks.
Efficacy assessments are conducted at Week 4, and Week 8 using a superiority testing framework. To control the overall Type I error rate across multiple primary and key secondary endpoints in Stage 2, a Hochberg multiplicity adjustment procedure will be applied. Evaluated endpoints include:
- Week 4 vIGA-AD Success (vIGA-AD Success defined as a score of 0 or 1 with at least 2 grade improvement).
- Week 4 EASI-75 (EASI-75 defined as at least a 75% reduction in Eczema Area Severity Index)
- Week 8 EASI-90 (EASI-90 defined as at least a 90% reduction in Eczema Area Severity Index)
- Week 8 EASI-100 (EASI-100 defined as 100% reduction in Eczema Area Severity Index)
Safety Monitoring:
Safety assessments include treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), local site tolerability monitoring, and concomitant medication reviews across the treatment and follow-up periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GX-03 | Experimental | Combination Product: GX-03Treatment Arm |
| Vehicle | Experimental | Other: VehicleVehicle Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-03Topical ointment | Combination product | GX-03 |
| VehicleOintment carrier | Other | Vehicle |
Primary outcome
vIGA-AD Success at Week 4
Time frame: At Day 28 (Week 4)
vIGA-AD Success defined as score of 0 (clear) or 1 (almost clear) with a ≥2-grade improvement from baseline at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
EASI-75 at Week 4
Time frame: At Day 28 (Week 4)
75% reduction from baseline in Eczema Area Severity Index (EASI) at Week 4. All Primary Outcome measures will be evaluated using the Hochberg-method.
EASI-90 at Week 8
Time frame: At Day 56 (Week 8)
90% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
EASI-100 at Week 8
Time frame: At Day 56 (Week 8)
100% reduction from baseline in Eczema Area Severity Index (EASI) at Week 8. All Primary Outcome measures will be evaluated using the Hochberg-method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Protection of participant privacy and re-identification risks Ongoing regulatory or commercial activities Intellectual property and competitive concerns Resource and practical barriers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GX-03 in people with Eczema Atopic Dermatitis and Eczema, run by Turn Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barry Reece, MS (9728714371, barry.reece@alsglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vIGA-AD Success at Week 4 (time frame: At Day 28 (Week 4)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.