Chronic Plaque PsoriasisPhase 2NCT00419666
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
A Phase 2 study testing Calcitriol 3mcg/g in people with Chronic Plaque Psoriasis, run by Galderma R&D at 7 sites in 2 countries.
Trial summary
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- Calcitriol 3mcg/g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Aug 2006to 24 Sep 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of chronic plaque psoriasis
- 10 - 35% BSA of involved skin
- Age 12 - 17
Who cannot join
- Other type of psoriasis (other than plaque)
- Significant abnormal lab findings
- Vit D insufficiency
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Dermatology Center For Children & Young Adults
Eagan, Minnesota, 55121
University of Texas-Houston Medical Center Dept of Dermatology
Houston, Texas, 77030
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205
Children's Hospital, Department of Pediatric and Adolescent Dermatology
San Diego, California, 92123
Center for Clinical Studies
Webster, Texas, 77598
Canada2 sites
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1B 3E1
Newlab Clinical Research, Inc.
St. John's, Newfoundland and Labrador, A1C 2H5
About this study
Official title: PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Calcitriol 3mcg/g
- Keywords
- Calcitriol, Psoriasis, PK, Adolescents
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitriol 3mcg/gDrug
Also called CD2027, Vectical
Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calcitriol 3mcg/g | Experimental | Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. Receives: Drug: Calcitriol 3mcg/g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Plasma Levels (Ctrough) of Calcitriol
Trough plasma levels (Ctrough) of calcitriol was reported.
Measured: Day 0 (Baseline), Day 14, Day 21, and Day 56
The Observed Peak Drug Concentration (Cmax) of Calcitriol
Cmax of calcitriol was reported.
Measured: Day 0 (Baseline), Day 21
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])
The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.
Measured: 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])
The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.
Measured: 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21
Time at Which Maximum Concentration (Cmax) Occurred (Tmax)
Tmax is the time to reach maximum concentration and was reported for calcitriol.
Measured: Day 0 (Baseline), Day 21
Secondary outcomes (4)
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.
Measured: From baseline (Day 0) up to Day 56
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.
Measured: From baseline (Day 0) up to Day 56
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56
Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.
Measured: From baseline (Day 0) up to Day 56
Number of Participants With Adverse Events
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.
Measured: From start of the study to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study start1 Aug 2006
- Primary completion24 Sep 2009
- Study completion24 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Graeber, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419666
- Sponsor's protocol ID
- RD.06.SPR.18102
- Status last verified
- Nov 2019
- First submitted
- 5 Jan 2007
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00419666
- Acronym / sponsor ID
- RD.06.SPR.18102
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Calcitriol, Psoriasis, PK, Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2006 (actual)
- Primary completion
- 24 Sep 2009 (actual)
- Study completion
- 24 Sep 2009 (actual)
- First posted
- 9 Jan 2007 (estimated)
- Results
- Posted 10 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcitriol 3mcg/g | Experimental | Drug: Calcitriol 3mcg/gParticipants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of chronic plaque psoriasis
- 10 - 35% BSA of involved skin
- Age 12 - 17
Key exclusion criteria (3 listed)
- Other type of psoriasis (other than plaque)
- Significant abnormal lab findings
- Vit D insufficiency
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 3mcg/gAlso: CD2027, VecticalCalcitriol 3mcg/g ointment applied twice daily for 56 weeks. | Drug | Calcitriol 3mcg/g |
Primary outcome
Trough Plasma Levels (Ctrough) of Calcitriol
Time frame: Day 0 (Baseline), Day 14, Day 21, and Day 56
Trough plasma levels (Ctrough) of calcitriol was reported.
The Observed Peak Drug Concentration (Cmax) of Calcitriol
Time frame: Day 0 (Baseline), Day 21
Cmax of calcitriol was reported.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])
Time frame: 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21
The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])
Time frame: 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21
The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.
Time at Which Maximum Concentration (Cmax) Occurred (Tmax)
Time frame: Day 0 (Baseline), Day 21
Tmax is the time to reach maximum concentration and was reported for calcitriol.
4 secondary outcomes
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56
Time frame: From baseline (Day 0) up to Day 56
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56
Time frame: From baseline (Day 0) up to Day 56
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56
Time frame: From baseline (Day 0) up to Day 56
Number of Participants With Adverse Events
Time frame: From start of the study to Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Graeber, MD study director
Galderma R&D
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcitriol 3mcg/g in people with Chronic Plaque Psoriasis, run by Galderma R&D at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Trough Plasma Levels (Ctrough) of Calcitriol (time frame: Day 0 (Baseline), Day 14, Day 21, and Day 56). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Feb 2021.