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NCT01563068 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis
A Phase 1 study, sponsored by Mayne Pharma International Pty.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01563068: Completed Phase 1 study, sponsored by Mayne Pharma International Pty.
NCT01563068 is a Phase 1 study that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01563068, a Phase 1 study, has completed, sponsored by Mayne Pharma International Pty.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 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 in which adolescent subjects (ages 12 to 16 years, inclusive) or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14 days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated
Primary Outcome
determine albumin-adjusted calcium, iPTH, alkaline phosphatase, and phosphorus
Interventions
- DRUG Calcipotriene 0.005% Foam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT01563068 record still lists
NCT01563068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Calcipotriene 0.005% Foam is the first listed.
NCT01563068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01563068 about?
NCT01563068 is a clinical study titled "Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With 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 in wh...
What is the current status of trial NCT01563068?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-04. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01563068?
The interventions under investigation include: Calcipotriene 0.005% Foam (DRUG).
Who is sponsoring clinical trial NCT01563068?
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 NCT01563068's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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