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.
NCT06673654
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Sun Pharmaceutical Industries, Inc.
Start date
2023-08-11
Number of sites
- 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
- Short title
- 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.
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-09-23
- First posted
- 2024-11-05
- Registry last updated
- 2024-11-05
- Primary completion date
- 2024-09-23
- Start date
- 2023-08-11
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06673654
- ClinicalTrials.gov ID
- NCT06673654
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Single masking
- Masked roles
- Investigators
Sources for study design
Demonstration of therapeutic equivalence, superiority, and safety of the Investigational Products.
Timeframe: Baseline to Week 8
The percentage of subjects in each treatment group with "Treatment Success" (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, at the Week 8 (Day 56 ± 4 days) visit.
Sources for outcomes
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 12 Years
- Healthy volunteers
- Yes
- 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.
- 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).
Sources for eligibility
- Taro Pharmaceuticals USA Inc.Hawthorne, United States
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Atopic eczema Primary condition