Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis
Public ClinicalTrials.gov record NCT01563068. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Calcipotriene Foam, 0.005%, Applied Under Maximal-Use Conditions in Adolescent Subjects (Ages 12 to 16 Years) With Plaque Psoriasis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01563068
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2012
- Primary completion
- Jul 31, 2015
- Completion
- Jul 31, 2015
- Last update posted
- May 10, 2018
2012 – 2015
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site | San Diego | California | 92123 | — |
| Investigational Site | Ormond Beach | Florida | 32174 | — |
| Investigational Site | Tampa | Florida | 33609 | — |
| Investigational Site | Marietta | Georgia | 30060 | — |
| Investigational Site | Chicago | Illinois | 60611 | — |
| Investigational Site | Indianapolis | Indiana | 46256 | — |
| Investigational Site | Louisville | Kentucky | 40217 | — |
| Investigational Site | Philadelphia | Pennsylvania | 19103 | — |
| Investigational Site | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01563068, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01563068 live on ClinicalTrials.gov.