CompletedPhase 2

A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis

United States3 participantsStarted 2025-04-21

Plain-language summary

The goal of this clinical trial is to learn if drug CGB-500 works to treat atopic dermatitis in subjects 12 years of age or older. It will also learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 decrease the severity of atopic dermatitis on the skin? What medical problems do participants have when taking drug CGB-500? Researchers will compare CGB-500 to a an approved product (1.5% ruxolitinib) to see if CGB-500 works to treat atopic dermatitis. Participants will: Apply CGB-500 and ruxolitinib to different locations on their body twice a day for four weeks. Visit the clinic six times for checkups and tests Keep a diary of their symptoms and when they apply the product

Who can participate

Age range12 Years

SexALL

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Exclusion criteria

✕. For 5 half-lives or 12 weeks (whichever is longer) - biologic agents (e.g., dupilumab).
✕. For 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g., mycophenolate or tacrolimus).
✕. For 2 weeks - UVA/UVB therapy, PUVA (psoralen plus ultraviolet) therapy, tanning booths, or non-prescription UV light sources.
✕. For 2 weeks - immunizations and sedating antihistamines unless on long-term stable regimen (nonsedating antihistamines are permitted).
✕. For 2 weeks - use of other topical treatments for atopic dermatitis (other than bland emollients). Diluted sodium hypochlorite "bleach" baths are allowed if they do not exceed 2 baths per week and their frequency remains the same throughout the trial.

What they're measuring

evaluate effectiveness

Timeframe: From enrollment to end of study at 4 weeks

Safety and tolerability

Timeframe: From enrollment to end of study at 4 weeks

Trial details

NCT IDNCT06923228

SponsorCAGE Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Atopic Dermatitis (AD) trials