Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
Public ClinicalTrials.gov record NCT01582932. 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 Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 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 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.
Study identification
- NCT ID
- NCT01582932
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 11 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, 2013
- Primary completion
- Jul 31, 2018
- Completion
- Jul 31, 2018
- Last update posted
- Jan 21, 2019
2013 – 2018
United States locations
- U.S. sites
- 36
- U.S. states
- 18
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35233 | — |
| Investigational Site | Rogers | Arkansas | 72758 | — |
| Investigational Site | Encino | California | 91436 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Santa Ana | California | 92705 | — |
| Not listed | Sherman Oaks | California | 91403 | — |
| Investigational Site | Hollywood | Florida | 33021 | — |
| Investigational Site | Jacksonville | Florida | 32204 | — |
| Not listed | Miami | Florida | 33014 | — |
| Investigational Site | Miami | Florida | 33136 | — |
| Investigational Site | Tampa | Florida | 33690 | — |
| Investigational Site | Alpharetta | Georgia | 30022 | — |
| Not listed | Atlanta | Georgia | 30342 | — |
| Investigational Site | Marietta | Georgia | 30060 | — |
| Investigational Site | Sandy Springs | Georgia | 30328 | — |
| Investigational Site | Chicago | Illinois | 60614 | — |
| Investigational Site | Plainfield | Indiana | 46188 | — |
| Not listed | Brighton | Massachusetts | 02135 | — |
| Investigational Site | Farmington Hills | Michigan | 48334 | — |
| Not listed | Saint Joseph | Missouri | 64506 | — |
| Investigational Site | St Louis | Missouri | 63104 | — |
| Investigational Site | St Louis | Missouri | 63117 | — |
| Investigational Site | New York | New York | 10467 | — |
| Investigational Site | Chapel Hill | North Carolina | 27516 | — |
| Investigational Site | Winston-Salem | North Carolina | 27157 | — |
| Investigational Site | Portland | Oregon | 97239 | — |
| Investigational Site | Hershey | Pennsylvania | 17033 | — |
| Not listed | Philadelphia | Pennsylvania | 19109 | — |
| Investigational Site | Austin | Texas | 78723 | — |
| Investigational Site | Houston | Texas | 77030 | — |
| Investigational Site | Houston | Texas | 77056 | — |
| Not listed | San Antonio | Texas | 78218 | — |
| Investigational Site | Salt Lake City | Utah | 84132-2409 | — |
| Investigational Site | Norfolk | Virginia | 23502 | — |
| Investigational Site | Spokane | Washington | 99202 | — |
| Investigational Site | Tacoma | Washington | 98418 | — |
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 NCT01582932, 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 Jan 21, 2019 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01582932 live on ClinicalTrials.gov.