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NCT03331523
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis
Phase 3 trial testing Calcipotriene/Betamethasone Dipropionate in Scalp Psoriasis in 643 participants. Completed in 25 October 2018.
25 October 2018
Quick facts
| Lead sponsor | Glenmark Pharmaceuticals Ltd. India |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 643 |
| Start date | 20 October 2017 |
| Primary completion | 25 October 2018 |
| Estimated completion | 25 October 2018 |
| Sites | 31 locations across United States |
Drugs / interventions tested
- Calcipotriene/Betamethasone Dipropionate
- Taclonex®
- Placebo
Conditions studied
- Scalp Psoriasis — all drugs for Scalp Psoriasis →
Sponsor
Glenmark Pharmaceuticals Ltd. India — full company profile →
Who can join
18 and older, any sex, with Scalp Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.
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 NCT03331523
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Glenmark Pharmaceuticals Ltd. India trials
Trials by the same sponsor.
- NCT05363202 — To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma · Phase 3 · unknown
- NCT03731091 — To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis · Phase 3 · completed
- NCT03444506 — Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Mol · Phase 2 · 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 NCT03331523 (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 Glenmark Pharmaceuticals Ltd. India
- Last refreshed: 21 December 2018
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/NCT03331523.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing