NCT06673654CompletedPhase 1
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.
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.
Source: ClinicalTrials.gov · Last updated 5 Nov 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 476 (actual)
- First submitted
- 2 Nov 2024
- Start date
- 11 Aug 2023
- Primary completion date
- 23 Sept 2024
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06673654
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 476
- From 11 Aug 2023 to the primary completion date, 23 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
Other illness
- Subjects with a history of hypersensitivity or allergy to Ruxolitinib and/or any of the study medication ingredients
- 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).
Other
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taro Pharmaceuticals USA Inc. Coordinator of this site? Confirm its status | Hawthorne | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.