Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

Part of paid clinical trials in Culver City, California.

Sponsor
Incyte Corporation
Study ID
NCT05127421
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib cream — DRUG
    Ruxolitinib cream 1.5% applied twice a day (BID)"
  • Vehicle — DRUG
    Vehicle cream applied twice a day (BID) to affected areas

Study Details

This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.

Key Dates

Start date
Nov 10, 2021
Status verified
Aug 2024
Primary completion
Aug 3, 2023
Completion
Sep 29, 2023

Study Design

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

Arms

  • Experimental: Double-blind Period: vehicle cream or Ruxolitinib cream 1.5% BID
    Participants will be treated with ruxolitinib cream 1.5% or vehicle cream twice a day (BID) in a double-blind fashion.
  • Experimental: Open Label Extension: Ruxolitiib cream 1.5%
    Patients will be treated with Ruxoltinib cream 1.5% twice per day (BID) during the open label extension period. Participants who complete the double-blind period will continue into this open-label extension period for an additional 4 weeks of treatment.

Primary Outcome Measure

Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4 [ Time Frame: Baseline; Week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Science37Culver CityCalifornia90230-

Find similar trials in Culver City, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Science37· Culver City, CA

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