Psoriasis VulgarisPhase 4NCT02125279
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
A Phase 4 study testing Calcitriol in people with Psoriasis Vulgaris, run by Galderma R&D at 16 sites in 5 countries.
Trial summary
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 16 sitesin 5 countries
- Study dates
- May 2014to May 2018
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 2 to 16 years and 11 months of age
- Clinical diagnosis of stable mild to moderate plaque psoriasis
Who cannot join
- Other forms of psoriasis
- Hypercalcemia
- Past history of kidney stones
- Vitamin D deficiency
- Other concomitant dermatological disease
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States8 sites
Arlington Research Center for Dermatology
Arlington, Texas, 76011
Advanced Skincare Surgery & Medcenter
Burbank, California, 91505
Shideler Clinical Research Center
Carmel, Indiana, 46032
Johnson Dermatology
Fort Smith, Arkansas, 72916
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
Montefiore Medical Center
New York, New York, 10467
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, 72758
University of South Florida
Tampa, Florida, 33612
Germany3 sites
Charité Universitätsmedizin Berlin
Berlin, 10117
University Hospital Carl Gustav Carus
Dresden, 01307
Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
Mainz, 55131
Canada2 sites
Lynderm Research Inc.
Markham, Ontario, L3P1X2
CHU Sainte-Justine
Montreal, Quebec, H3T1C5
Italy2 sites
Padova University Hospital
Padova, 35128
University of Parma
Parma, 43126
About this study
Official title: A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 mo of Age) With Mild to Moderate Plaque Psoriasis
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Calcitriol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
| Study group | Role | What they receive |
|---|---|---|
| Calcitriol ointment | Experimental | Not described Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Screening in Serum Albumin Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Measured: Screening, Week 4
Change From Screening in Serum Albumin Levels at Week 8
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Measured: Screening, Week 8
Change From Screening in Serum Albumin Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Measured: Screening, Week 12
Change From Screening in Serum Albumin Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Measured: Screening, Week 20
Change From Screening in Serum Albumin Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Measured: Screening, Week 26
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.
Measured: Screening, Week 30 (Follow-up)
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.
Measured: Screening, Week 12
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.
Measured: Screening, Week 26
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.
Measured: Screening, Week 30 (Follow-up)
Change From Screening in Serum Phosphate Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Measured: Screening, Week 4
Change From Screening in Serum Phosphate Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Measured: Screening, Week 12
Change From Screening in Serum Phosphate Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Measured: Screening, Week 20
Change From Screening in Serum Phosphate Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Measured: Screening, Week 26
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.
Measured: Screening, Week 30 (Follow-up)
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Measured: Screening, Week 4
Change From Screening in Serum Parathyroid Hormone Levels at Week 8
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Measured: Screening, Week 8
Change From Screening in Serum Parathyroid Hormone Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Measured: Screening, Week 12
Change From Screening in Serum Parathyroid Hormone Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Measured: Screening, Week 20
Change From Screening in Serum Parathyroid Hormone Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Measured: Screening, Week 26
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.
Measured: Screening, Week 30 (Follow-up)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.
Measured: Up to Week 30
Secondary outcomes (3)
Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree).
Measured: Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Pruritus Score at Each Visit
Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.
Measured: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit
Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.
Measured: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2018
- Study completionMay 2018
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 Psoriasis VulgarisStudies 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
- 54 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, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125279
- Sponsor's protocol ID
- RD.06.SPR.18131
- Status last verified
- Dec 2019
- First submitted
- 28 Mar 2014
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- 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
- A Multicenter Open Label Uncontrolled Study of the Long Term Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 26 Weeks in Pediatric Subjects (2 to 16 Years and 11 mo of Age) With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02125279
- Acronym / sponsor ID
- RD.06.SPR.18131
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Posted 29 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcitriol ointment | Experimental | Drug: Calcitriol |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female 2 to 16 years and 11 months of age
- Clinical diagnosis of stable mild to moderate plaque psoriasis
Key exclusion criteria (5 listed)
- Other forms of psoriasis
- Hypercalcemia
- Past history of kidney stones
- Vitamin D deficiency
- Other concomitant dermatological disease
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 | Calcitriol ointment |
Primary outcome
Change From Screening in Serum Albumin Levels at Week 4
Time frame: Screening, Week 4
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Change From Screening in Serum Albumin Levels at Week 8
Time frame: Screening, Week 8
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Change From Screening in Serum Albumin Levels at Week 12
Time frame: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Change From Screening in Serum Albumin Levels at Week 20
Time frame: Screening, Week 20
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Change From Screening in Serum Albumin Levels at Week 26
Time frame: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)
Time frame: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12
Time frame: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26
Time frame: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)
Time frame: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.
Change From Screening in Serum Phosphate Levels at Week 4
Time frame: Screening, Week 4
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Change From Screening in Serum Phosphate Levels at Week 12
Time frame: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Change From Screening in Serum Phosphate Levels at Week 20
Time frame: Screening, Week 20
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Change From Screening in Serum Phosphate Levels at Week 26
Time frame: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)
Time frame: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
Time frame: Screening, Week 4
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 8
Time frame: Screening, Week 8
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 12
Time frame: Screening, Week 12
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 20
Time frame: Screening, Week 20
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 26
Time frame: Screening, Week 26
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)
Time frame: Screening, Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 30
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.
3 secondary outcomes
Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
Time frame: Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Pruritus Score at Each Visit
Time frame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit
Time frame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
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.
- Individual participant dataSharing planned: No
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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, LLC
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitriol in people with Psoriasis Vulgaris, run by Galderma R&D at 16 sites in 5 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 2 inclusion and 5 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 16 sites in United States, Germany, Canada, Italy, Belgium. 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 29 Nov 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?
Change From Screening in Serum Albumin Levels at Week 4 (time frame: Screening, Week 4). The study lists 21 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.