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NCT01582932 · ClinicalTrials.gov registry record · Phase 1
Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
A Phase 1 study, sponsored by Mayne Pharma International Pty.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01582932 is a Phase 1 study that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 36 participants.
The verdict
NCT01582932, a Phase 1 study, has completed, sponsored by Mayne Pharma International Pty.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated.
Interventions
- DRUG Calcipotriene 0.005% Foam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-04 |
| Est. Completion | 2018-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01582932
The ClinicalTrials.gov registry entry for NCT01582932 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayne Pharma International Pty, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Calcipotriene 0.005% Foam is the first listed.
NCT01582932 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01582932 about?
NCT01582932 is a clinical study titled "Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis". Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evalu...
What is the current status of trial NCT01582932?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-04. Estimated completion is 2018-08.
What interventions are being tested in trial NCT01582932?
The interventions under investigation include: Calcipotriene 0.005% Foam (DRUG).
Who is sponsoring clinical trial NCT01582932?
This trial is sponsored by Mayne Pharma International Pty, which has 6 total clinical trials registered on ClinicalTrials.gov.
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