GX-03 for Eczema

(GX-03 in AD Trial)

Overseen By Barry Reece, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Turn Therapeutics

Must not be taking: Immunosuppressives, Anti-inflammatories

Disqualifiers: Pregnancy, Skin conditions, Medical conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized, double-blind, vehicle-controlled clinical study designed to evaluate the efficacy and safety of GX-03, a topically applied emollient, in adult subjects with moderate to severe eczema. Approximately 120 adult participants will be enrolled and randomized in a 1:1 ratio to receive either GX-03 or a petrolatum-based vehicle control for 8 consecutive weeks. Efficacy will be assessed using validated clinical outcome measures, including the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), and the Peak Pruritus Numeric Rating Scale (PP-NRS). Safety will be evaluated through monitoring of treatment-emergent adverse events throughout the study period.

Are You a Good Fit for This Trial?

Adults aged 18-70 with moderate to severe eczema can join this study. They must be in good health, able to understand English, and willing to follow the study's rules like using only the assigned product on affected areas for 8 weeks.

Inclusion Criteria

I am in good health overall.

Agreement to use only the assigned study product on designated areas of interest for the duration of the study

Ability to read, understand, and provide written informed consent in English

Exclusion Criteria

Pregnant, breastfeeding, or planning pregnancy during the study

Any medical condition that, in the investigator's judgment, places the subject at undue risk or compromises study integrity

I don't have damaged or altered skin where they will test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GX-03 or a vehicle control, applied topically to affected areas at least twice daily for 8 weeks

8 weeks

3 visits (in-person), weekly telephone check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GX-03

Trial Overview

The trial is testing GX-03, a new cream for eczema against a petrolatum-based control (like Vaseline). Participants are randomly chosen to use one of these treatments for two months while doctors track their skin's improvement using specific scoring systems.

How Is the Trial Designed?

Group I: GX-03 Experimental Treatment 1 Intervention

Treatment Arm

Group II: Vehicle Placebo Group 1 Intervention

Vehicle Control

Who Is Running the Clinical Trial?

Turn Therapeutics

Lead Sponsor

Trials

1

Recruited

90+