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

Sponsor
CAGE Bio Inc.
Study ID
NCT05487963
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib Citrate — DRUG
    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.
  • placebo ointment — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 9, 2022
Status verified
May 2024
Primary completion
Jun 30, 2023
Completion
Jul 30, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CGB-500 topical ointment, 1% tofacitinib
  • Placebo Comparator: Vehicle topical ointment

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 8 weeks ]

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