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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.
Phase 1 trial testing Ruxolitinib Topical Cream 1.5% in Atopic Dermatitis in 476 participants. Completed in 23 September 2024.
23 September 2024
Quick facts
| Lead sponsor | Sun Pharmaceutical Industries, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 476 |
| Start date | 11 August 2023 |
| Primary completion | 23 September 2024 |
| Estimated completion | 23 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ruxolitinib Topical Cream 1.5% — full drug profile →
- OPZELURA (Ruxolitinib) Cream — full drug profile →
- Placebo
Conditions studied
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
Sponsor
Sun Pharmaceutical Industries, Inc. — full company profile →
Who can join
12 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06673654
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
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- NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting
Other Sun Pharmaceutical Industries, Inc. trials
Trials by the same sponsor.
- NCT07469228 — A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne V · Phase 1 · completed
- NCT06733402 — A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENC · Phase 1 · completed
- NCT06673641 — A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceutica · Phase 1 · completed
- NCT06305637 — A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. · Phase 1 · completed
- NCT06063473 — A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06673654 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Pharmaceutical Industries, Inc.
- Last refreshed: 5 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06673654.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing