Clinical trial NCT06673654: 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.
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and Both Active Treatments to a Placebo Control in the Treatment of Mild-to-Moderate Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2024-11-05
Enrollment: 476
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream and both active treatments to a placebo control in the treatment of mild-to-moderate atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 years
* Subjects who are 18 years of age or older must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
* Subjects who have a clinical diagnosis of AD as defined by the criteria of Hanifin and Rajka.
* Subjects who have a clinical diagnosis of AD for at least 2 years.
* Subjects who have IGA Score of 2 (Mild) or 3 (Moderate) for AD severity.
* Subjects who have AD involvement of 3-20% of the body surface area (BSA) and does not include the scalp.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a history of hypersensitivity or allergy to Ruxolitinib and/or any of the study medication ingredients
* Subjects with unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of AD (e.g., other types of eczema, pigmentation, or extensive scarring).

Primary outcomes:
measure: Demonstration of therapeutic equivalence, superiority, and safety of the Investigational Products.
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: Catawba Research, LLC
name: Andy Silverman
role: STUDY_CHAIR
References: