Plaque PsoriasisPhase 4NCT02186665
Plaque Psoriasis Study in Pediatric Subjects
A Phase 4 study testing calcitriol ointment in people with Plaque Psoriasis, run by Galderma R&D at 34 sites in 7 countries.
Trial summary
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis. 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 ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 34 sitesin 7 countries
- Study dates
- Jul 2014to Jan 2016
- 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 2 to 12 years 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
34 sites in 7 countries.
34 sites in 7 countries
United States12 sites
DermResearch
Austin, Texas, 78759
David Stoll, MD
Beverly Hills, California, 90212
Dermatology and Laser Center of Charleston
Charleston, South Carolina, 29414
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Dermatology Specialists Research
Louisville, Kentucky, 40202
RCMC Center for Dermatology at Linden Oaks
Rochester, New York, 14625
Center for Dermatology and Laser Surgery
Sacramento, California, 95819
Clinical Trials of Texas
San Antonio, Texas, 78229
Montefiore Medical Center
The Bronx, New York, 10467
Jordan Valley Dermatology
West Jordan, Utah, 84088
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona-Barcelona, 8916
Hospital Sant Joan de Deu
Esplugues de Llobregat, 8950
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, 28702
Germany5 sites
Universitätsklinikum Erlangen, Hautklinik
Erlangen, 91054
Praxis Dr.Beate Schwarz
Langenau, 89129
Universitäts-Hautklinik Mainz, Johannes Gutenberg-Universität Mainz
Mainz, 55131
Technical University Munich
München, 80802
University of Tübingen
Tübingen, 72076
Italy4 sites
PO G. Rodolico, AOU Policlinico Vittorio Emanuele
Catania, 95123
Padova University Hospital
Padova, 35128
University of Parma
Parma, 43126
Policlinico Tor Vergata
Rome, 00133
Belgium3 sites
UCL Saint Luc
Brussels, 1200
UZ Ghent
Ghent, 9000
CHU de Liège
Liège, 4000
Hungary3 sites
Heim Pál Gyermekkórház; Bőrgyógyászati Osztály
Budapest, 1089
Pécsi Tudományegyetem; Bőr-, Nemikórtani és Onkodermatológiai Klinika
Pécs, 7632
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ; Bőrgyógyászati és Allergológiai Klinika
Szeged, 6720
About this study
Official title: A Multicenter, Randomized, Double Blind, Parallel Group, Vehicle Controlled, Study of the Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 8 Weeks in Pediatric Subjects (2 to 12 Years of Age) With Mild to Moderate Plaque Psoriasis
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- calcitriol ointment, placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriol ointmentDrug
placebo comparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| calcitriol ointment | Experimental | calcitriol 3 mcg/g ointment Receives: Drug: calcitriol ointment |
| placebo | Placebo comparator | placebo comparator Receives: Drug: placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Investigator's Global Assessment (IGA)
The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).
The IGA was evaluated at each visit on the following 0 to 4 point scale:
0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation
- - Almost Clear: Just perceptible erythema, no induration, and no scaling
- - Mild: Mild erythema, no induration, and mild or no scaling
- - Moderate: Moderate erythema, mild induration, and mild or no scaling
- - Severe: Severe erythema, moderate to severe induration, and scaling of any degree
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionJan 2016
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 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
- NCT02186665
- Sponsor's protocol ID
- RD.06.SPR.18132
- Status last verified
- Mar 2017
- First submitted
- 8 Jul 2014
- 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
- A Multicenter, Randomized, Double Blind, Parallel Group, Vehicle Controlled, Study of the Safety and Efficacy of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 8 Weeks in Pediatric Subjects (2 to 12 Years of Age) With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02186665
- Acronym / sponsor ID
- RD.06.SPR.18132
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Jul 2014 (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 compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcitriol ointment | Experimental | Drug: calcitriol ointmentcalcitriol 3 mcg/g ointment |
| placebo | Placebo comparator | Drug: placebo comparatorplacebo comparator |
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 2 to 12 years 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 ointment | Drug | calcitriol ointment |
| placebo comparator | Drug | placebo |
Primary outcome
Success of Investigator's Global Assessment (IGA)
Time frame: Baseline to Week 8
The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF). The IGA was evaluated at each visit on the following 0 to 4 point scale: 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
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
RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
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RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
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Not yet recruitingObservational study
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
Plaque Psoriasis
RecruitingPhase 2
An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis
Moderate-to-severe Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar 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, MD study director
Galderma R&D, LLC
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing calcitriol ointment in people with Plaque Psoriasis, run by Galderma R&D at 34 sites in 7 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 34 sites in United States, Spain, Germany, Italy, Belgium and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
Success of Investigator's Global Assessment (IGA) (time frame: Baseline to Week 8). 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.