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NCT03506477 · ClinicalTrials.gov registry record · Phase 4
Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT03506477: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03506477 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03506477, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.
Primary Outcome
Number of patients at week 4 who achieved treatment success according to Investigator's Global Assessment (IGA mod 2011) of the entire body including scalp. IGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as IGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or IGA of clear (0) for patients with mild disease at baseline.
Interventions
- DRUG Vehicle foam
- DRUG Enstilar® foam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-05-21 |
| Est. Completion | 2019-09-25 |
| Phase | Phase 4 |
What the finished NCT03506477 record still lists
NCT03506477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle foam is the first listed.
NCT03506477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03506477 about?
NCT03506477 is a clinical study titled "Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color". This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST IV-VI). This study will a...
What is the current status of trial NCT03506477?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2018-05-21. Estimated completion is 2019-09-25.
What interventions are being tested in trial NCT03506477?
The interventions under investigation include: Vehicle foam (DRUG), Enstilar® foam (DRUG).
Who is sponsoring clinical trial NCT03506477?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03506477's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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