drugset / Trial / NCT05487963

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

NCT05487963

Phase 1/2 Completed 40 enrolled CAGE Bio Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Tofacitinib Small molecule 1 % Topical

Indications