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Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis

NCT05487963 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-13

No results posted yet for this study

Summary

The objective of the proposed study is to evaluate the tolerability and effectiveness of a 1% topical ointment of tofacitinib for the treatment of mild to moderate atopic dermatitis in adults. Adult patients with a diagnosis of atopic dermatitis for at least 6 months will be treated with the test product or placebo for a period of 8 weeks with a follow-up visit at 12 weeks. The primary endpoints are safety and tolerability of CGB-500 Ointment and a comparison of effectiveness of CGB-500 Ointment and Vehicle Ointments in treating lesion(s) of mild to moderate atopic dermatitis.

Conditions

Interventions

DRUG

Tofacitinib Citrate

Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day.

OTHER

placebo ointment

Topical application of a pea-sized amount of ointment (active or vehicle) over a maximum surface of 30 cm2 up to 2 times a day.

Sponsors & Collaborators

  • CAGE Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2023-06-30
Completion
2023-07-30

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05487963 on ClinicalTrials.gov