Plaque PsoriasisPhase 4NCT01766440
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
A Phase 4 study testing Calcitriol 3 mcg/g ointment in people with Plaque Psoriasis, run by Galderma R&D at 8 sites in United States.
Trial summary
The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Calcitriol 3 mcg/g ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2013to Nov 2015
- Phase
- Phase 4
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female pediatric subjects, 2 to 12 years of age inclusive at screening
- Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp)
Who cannot join
- Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection
- Vitamin D deficiency at screening
- Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening
- Subjects with secondary hyperparathyroidism at screening
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Menter Dermatology Research Institute
Dallas, Texas, 75246
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Rady Children's Hospital - Pediatric and Adolescent Dermatology
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 14 Days Under Conditions of Maximal Use in Pediatric Subjects (2 to 12 Years of Age) With Plaque Psoriasis
The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.
- Conditions
- Plaque Psoriasis
- Being tested
- Calcitriol 3 mcg/g ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitriol 3 mcg/g ointmentDrug
Topical ointment; twice daily application
| Study group | Role | What they receive |
|---|---|---|
| Calcitriol 3 mcg/g ointment | Experimental | Topical application every 12 hours for 14 consecutive days Receives: Drug: Calcitriol 3 mcg/g ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Calcitriol Plasma Level
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Measured: Day 14
Cmin of Calcitriol Plasma Level
Cmin of calcitriol plasma level at Day 14
Measured: Day 14
Tmax of Calcitriol Plasma Level
Tmax of calcitriol plasma level at Day 14
Measured: Day 14
AUC (0-6h) of Calcitriol Plasma Level
AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
Measured: Day 14
AUC (0-9h) of Calcitriol Plasma Level
AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)
Measured: Day 14
AUC (0-12h) of Calcitriol Plasma Level
AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Graeber, M.D., Study director, Galderma R&D, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766440
- Sponsor's protocol ID
- RD.06. SPR.18104
- Status last verified
- Apr 2017
- First submitted
- 9 Jan 2013
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Pharmacokinetics and Pharmacodynamics of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 14 Days Under Conditions of Maximal Use in Pediatric Subjects (2 to 12 Years of Age) With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01766440
- Acronym / sponsor ID
- RD.06. SPR.18104
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcitriol 3 mcg/g ointment | Experimental | Drug: Calcitriol 3 mcg/g ointmentTopical application every 12 hours for 14 consecutive days |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female pediatric subjects, 2 to 12 years of age inclusive at screening
- Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp)
Key exclusion criteria (4 listed)
- Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection
- Vitamin D deficiency at screening
- Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening
- Subjects with secondary hyperparathyroidism at screening
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 3 mcg/g ointmentTopical ointment; twice daily application | Drug | Calcitriol 3 mcg/g ointment |
Primary outcome
Cmax of Calcitriol Plasma Level
Time frame: Day 14
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Cmin of Calcitriol Plasma Level
Time frame: Day 14
Cmin of calcitriol plasma level at Day 14
Tmax of Calcitriol Plasma Level
Time frame: Day 14
Tmax of calcitriol plasma level at Day 14
AUC (0-6h) of Calcitriol Plasma Level
Time frame: Day 14
AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
AUC (0-9h) of Calcitriol Plasma Level
Time frame: Day 14
AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)
AUC (0-12h) of Calcitriol Plasma Level
Time frame: Day 14
AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)
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.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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, M.D. study director
Galderma R&D, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitriol 3 mcg/g ointment in people with Plaque Psoriasis, run by Galderma R&D at 8 sites in United States.
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 2 inclusion and 4 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 8 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 31 Mar 2017). 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?
Cmax of Calcitriol Plasma Level (time frame: Day 14). The study lists 6 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.