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NCT03731091 · ClinicalTrials.gov registry record · Phase 3
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).
A Phase 3 study, sponsored by Glenmark Pharmaceuticals Ltd. India.
- Completed
- Registry status
- Phase 3
- Development phase
- 494
- Enrollment target
NCT03731091: Completed Phase 3 study, sponsored by Glenmark Pharmaceuticals Ltd. India.
NCT03731091 is a Phase 3 study that has completed, run by Glenmark Pharmaceuticals Ltd. India. The registered enrollment target is 494 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03731091, a Phase 3 study, has completed, sponsored by Glenmark Pharmaceuticals Ltd. India.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 494 participants
- Enrollment target
Study Summary
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)
Primary Outcome
Treatment success defined as none or minimal disease , a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity
Interventions
- DRUG Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%
- DRUG Enstilar® foam (LEO Pharma Inc.)
- OTHER Placebo of Calcipotriene/ betamethasone dipropionate topical foam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2018-10-31 |
| Est. Completion | 2020-03-17 |
| Phase | Phase 3 |
What the finished NCT03731091 record still lists
NCT03731091 is an interventional study that assigns participants to a tested intervention. The registered 494 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 3 interventions - of which Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% is the first listed.
NCT03731091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03731091 about?
NCT03731091 is a clinical study titled "To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).". A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Phar...
What is the current status of trial NCT03731091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2018-10-31. Estimated completion is 2020-03-17.
What interventions are being tested in trial NCT03731091?
The interventions under investigation include: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% (DRUG), Enstilar® foam (LEO Pharma Inc.) (DRUG), Placebo of Calcipotriene/ betamethasone dipropionate topical foam (OTHER).
Who is sponsoring clinical trial NCT03731091?
This trial is sponsored by Glenmark Pharmaceuticals Ltd. India, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03731091's enrollment target sits among peer trials
494 779th of 2000 higher than 1,222 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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