A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for the Treatment of Mild-to-Moderate Atopic Dermatitis.

Part of paid clinical trials in Hawthorne, New York.

Sponsor
Sun Pharmaceutical Industries, Inc.
Study ID
NCT06673654
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ruxolitinib Topical Cream 1.5% — DRUG
    The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
  • OPZELURA (Ruxolitinib) Cream — DRUG
    The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
  • Placebo — DRUG
    The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.

Study Details

To demonstrate the therapeutic equivalence and safety of Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) and OPZELURA (Ruxolitinib) Cream in the treatment of mild-to-moderate atopic dermatitis

Key Dates

Start date
Aug 11, 2023
Status verified
Oct 2023
Primary completion
Sep 23, 2024
Completion
Sep 23, 2024

Study Design

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

Arms

  • Experimental: Ruxolitinib Topical Cream 1.5%
    The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
  • Active Comparator: OPZELURA (Ruxolitinib) Cream
    The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.
  • Placebo Comparator: Placebo Control
    The investigational product is to be self-administered by applying a thin layer twice daily to cover the affected areas up to 20% body surface area for approximately 8 weeks. The maximum weekly dose of the study drug should not exceed 60 g.

Primary Outcome Measure

Demonstration of therapeutic equivalence, superiority, and safety of the Investigational Products. [ Time Frame: Baseline to Week 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Taro Pharmaceuticals USA Inc.HawthorneNew York10532-

Find similar trials in Hawthorne, NY

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Taro Pharmaceuticals USA Inc.· Hawthorne, NY

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