PsoriasisNCT00006275
Study of Topical Calcitriol in Children With Psoriasis
A study testing calcitriol in people with Psoriasis, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- calcitriol
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Jul 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of psoriasis At least 2 lesions with area at least 30-50 cm2
--Prior/Concurrent Therapy--
No other concurrent therapy for psoriasis No concurrent calcium supplements greater than 1,000 mg/day No concurrent prednisone or other drugs affecting serum or urine calcium levels
--Patient Characteristics--
Renal: No high blood or urinary calcium levels
Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception
About this study
OBJECTIVES:
- Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.
Read the detailed description
PROTOCOL OUTLINE: Patients apply topical calcitriol in petrolatum on a psoriatic lesion daily. Patients also apply petrolatum without calcitriol to another psoriatic lesion daily.
Patients have both lesions photographed prior to therapy, monthly during therapy, and at the completion of therapy. Lesions are assessed weekly for 1 month and then every 2 weeks while on study. Blood samples are collected every 1 to 2 months and urine samples are collected every 2 weeks while on study.
- Conditions
- Psoriasis
- Being tested
- calcitriol
- Keywords
- dermatologic disorders, psoriasis, rare disease
- Medical subject headings
- Psoriasis, Skin Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2000 (estimated)
- Study startJul 2000
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Boston University
- Investigators
- Michael F. Holick, Study chair, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006275
- Sponsor's protocol ID
- 199/15372
- Other IDs
- BUSM-90-106
- Status last verified
- Sep 2000
- First submitted
- 11 Sep 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Topical Calcitriol in Children With Psoriasis
- ClinicalTrials.gov ID
- NCT00006275
- Acronym / sponsor ID
- 199/15372
- Conditions
- Psoriasis
- Keywords
- dermatologic disorders, psoriasis, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Boston University
- Study start
- Jul 2000
- Study completion
- Jul 2000
- First posted
- 12 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.
Detailed description
PROTOCOL OUTLINE: Patients apply topical calcitriol in petrolatum on a psoriatic lesion daily. Patients also apply petrolatum without calcitriol to another psoriatic lesion daily.
Patients have both lesions photographed prior to therapy, monthly during therapy, and at the completion of therapy. Lesions are assessed weekly for 1 month and then every 2 weeks while on study. Blood samples are collected every 1 to 2 months and urine samples are collected every 2 weeks while on study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcitriol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F. Holick study chair
Boston University
Questions about this trial
What is this clinical trial studying?
A study testing calcitriol in people with Psoriasis, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.