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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: Completed Phase 1 study, sponsored by Mayne Pharma International Pty.
NCT01582932 is a Phase 1 study that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the safety and tolerability of calcipotriene foam, 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. An evaluation of treatment effect will include changes in ISGA scores of body and scalp psoriasis from baseline. Safety will be assessed based on vital signs, reported adverse events (AEs), use of concomitant medications, and application site tolerability assessments.
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 |
What the finished NCT01582932 record still lists
NCT01582932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Calcipotriene 0.005% Foam is the first listed.
NCT01582932 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01582932's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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