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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 is a Phase 1 study that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 18 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01563068
The ClinicalTrials.gov registry entry for NCT01563068 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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.
NCT01563068 reports 0 study locations.
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.
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