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Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

NCT06810050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-02

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if CGB-500 works to treat atopic dermatitis in participants ages 12 and older. The goal is also to learn about the safety of CGB-500. The main questions it aims to answer are:

Does CGB-500 improve atopic dermatitis by decreasing the area affected and the severity of the lesions? What medical problems do participants have when taking CGB500? Researchers will compare CGB-500 to a placebo (a look-alike substance that contains no drug) to see if CGB-500 works to treat atopic dermatitis.

Participants will:

Take CGB-500 or a placebo every day for 8 weeks. Visit the clinic once every 2 weeks for the first month and at the end of 8 weeks.

Keep a diary of when they use the product and complete a form about their symptoms including itching.

Conditions

  • Atopic Dermatitis (AD)

Interventions

DRUG

CGB-500 with 0.5% tofacitinib

CGB-500 is a proprietary ointment formulation

DRUG

CGB-500 Ointment with 1% tofacitinib

CGB-500 is a proprietary ointment formulation

DRUG

Vehicle (placebo)

placebo ointment

Sponsors & Collaborators

  • CAGE Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2025-08-30
Completion
2025-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810050 on ClinicalTrials.gov