PsoriasisPhase 1NCT01582932
Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
A Phase 1 study testing Calcipotriene 0.005% Foam in people with Psoriasis, run by Mayne Pharma International Pty Ltd at 36 sites in United States.
Trial summary
Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Calcipotriene 0.005% Foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 36 sitesUnited States
- Study dates
- Apr 2013to Aug 2018
- Phase
- Phase 1
- 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent
- For the maximum-use cohort:
- ISGA of 3 or higher at Screening (see Appendix 2). Ages 7 to 11 - at least 10% total BSA with some scalp involvement (See Appendix 1).
- Ages 2 to 6 - at least 3% total BSA (napkin psoriasis included) with some scalp involvement (See Appendix 1).
- -For the general use cohort, an ISGA score of 2 or 3 at Screening with no BSA minimum.
Who cannot join
- Any inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis
- Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative, or pustular psoriasis
- Use of any topical treatments that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, vitamin D derivatives, coal tar, tazarotene, medicated shampoos, or anthralin, within 2 weeks prior to enrollment
- Use of nonbiologic systemic antipsoriatic therapy (eg, corticosteroids, psoralen, retinoids, methotrexate, cyclosporine, other immunosuppressive agents), biologic therapy (eg, adalimumab, etanercept, golimumab, infliximab, ustekinumab), or phototherapy (eg, psoralen and ultraviolet A [PUVA], ultraviolet B [UVB]) within 4 weeks prior to enrollment
- Use of or need for initiation of any nonpsoriatic therapy that might affect psoriasis (including antimalarials, β-blockers, interferon, or lithium) within 4 weeks prior to enrollment
- Use of medications that affect or change calcium and parathyroid hormone (PTH) concentrations or interfere with the measurement of calcium or PTH concentrations within 4 weeks prior to enrollment
Show all 14Show fewer
- Known difficult venous access beyond that expected for subject age
- Average daily ingestion of more than 2000 mg of elemental calcium or more than 1000 IU of vitamin D within 2 weeks prior to enrollment
- History of hypersensitivity, known allergy, or other adverse reaction to calcipotriene or other vitamin D analogs or to any component of the study product
- Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
- Use of any investigational therapy within 4 weeks prior to enrollment
- Pregnant or breast feeding female or females who do not use contraception
- Current immunosuppression
- Albumin-adjusted serum calcium at screening that is above the upper limit of normal
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Investigational Site
Alpharetta, Georgia, 30022
Study site
Atlanta, Georgia, 30342
Investigational Site
Austin, Texas, 78723
Investigational Site
Birmingham, Alabama, 35233
Study site
Brighton, Massachusetts, 02135
Investigational Site
Chapel Hill, North Carolina, 27516
Investigational Site
Chicago, Illinois, 60614
Investigational Site
Encino, California, 91436
Investigational Site
Farmington Hills, Michigan, 48334
Study site
Fountain Valley, California, 92708
Investigational Site
Hershey, Pennsylvania, 17033
Investigational Site
Hollywood, Florida, 33021
Investigational Site
Houston, Texas, 77030
Investigational Site
Houston, Texas, 77056
Investigational Site
Jacksonville, Florida, 32204
Investigational Site
Marietta, Georgia, 30060
Study site
Miami, Florida, 33014
Investigational Site
Miami, Florida, 33136
Investigational Site
New York, New York, 10467
Investigational Site
Norfolk, Virginia, 23502
Study site
Philadelphia, Pennsylvania, 19109
Investigational Site
Plainfield, Indiana, 46188
Investigational Site
Portland, Oregon, 97239
Investigational Site
Rogers, Arkansas, 72758
Study site
Saint Joseph, Missouri, 64506
Investigational Site
Salt Lake City, Utah, 84132-2409
Study site
San Antonio, Texas, 78218
Investigational Site
Sandy Springs, Georgia, 30328
Study site
Santa Ana, California, 92705
Study site
Sherman Oaks, California, 91403
Investigational Site
Spokane, Washington, 99202
Investigational Site
St Louis, Missouri, 63104
Investigational Site
St Louis, Missouri, 63117
Investigational Site
Tacoma, Washington, 98418
Investigational Site
Tampa, Florida, 33690
Investigational Site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years) With Plaque Psoriasis
Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated.
Read the detailed description
This is a multicenter, open-label, Phase 1 study in a total of 75 pediatric subjects, ages 2 to 11 years, inclusive, with mild or moderate plaque psoriasis.
The study will enroll sufficient subjects with plaque psoriasis and an ISGA score of mild to moderate (score of 2 or 3) at Baseline to ensure 50 evaluable subjects in a general use cohort.
In addition, a sufficient number of subjects with moderate plaque psoriasis will be enrolled to ensure 25 evaluable subjects in a 'maximum-use' cohort that have:
- At least 10% total BSA with some scalp involvement (15 evaluable subjects ages 7 to 11 years) or B. At least 3% total BSA with some scalp involvement (10 evaluable subjects ages 2 to 6 years). "Napkin" psoriasis (psoriasis in the diaper area) can be included in the BSA calculation for this age group.
Subjects or their caregivers will apply a thin layer of study product twice a day to the treatment areas for 8 weeks. Any new psoriatic lesions appearing in treatment areas during the treatment period should also be treated with study product. Safety assessments (adverse event and serious adverse event query) will occur at all study visits. Treatment effect assessments, urine calcium metabolism assessments, and application site tolerability assessments will be performed for all subjects at all in-clinic visits. A blood sample will be taken from all subjects at Screening for evaluation of pharmacodynamic (PD) and 2,5-OH vitamin D levels, an additional blood draw for PD parameters will be taken at Week 2 for the maximum-use cohort only. Blood sampling for pharmacokinetic (PK) measurements will be performed in the maximum-use cohort at Screening and Week 2.
- Conditions
- Psoriasis
- Being tested
- Calcipotriene 0.005% Foam
- Keywords
- plaque psoriasis, pediatric, mild, moderate
- Medical subject headings
- Psoriasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriene 0.005% FoamDrug
Also called Sorilux
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriene 0.005% Foam | Experimental | Foam is a vitamin D3 analog (calcipotriene) foam 0.005%. It is applied twice a day for 8 weeks to psoriasis lesions (except the face). Receives: Drug: Calcipotriene 0.005% Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment effect and change in ISGA scores of body and scalp psoriasis (Safety and Tolerability)
To evaluate the safety and tolerability of calcipotriene foam, 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. An evaluation of treatment effect will include changes in ISGA scores of body and scalp psoriasis from baseline. Safety will be assessed based on vital signs, reported adverse events (AEs), use of concomitant medications, and application site tolerability assessments.
Measured: 56 weeks
Secondary outcomes (2)
Plasma concentrations (trough) of calcipotriene
Describe the plasma concentrations (trough) of calcipotriene following administration of foam, 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with moderate plaque psoriasis.
Measured: 8 weeks
Pharmacodynamic effect
To evaluate the pharmacodynamic effect (ie, calcium metabolism) of calcipotriene foam 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2013
- Primary completionAug 2018
- Study completionAug 2018
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayne Pharma International Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Stuart Mudge, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582932
- Sponsor's protocol ID
- STF115469
- Status last verified
- Jan 2019
- First submitted
- 29 Mar 2012
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years) With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01582932
- Acronym / sponsor ID
- STF115469
- Conditions
- Psoriasis
- Keywords
- plaque psoriasis, pediatric, mild, moderate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayne Pharma International Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 23 Apr 2012 (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.
Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study evaluating calcipotriene foam, 0.005% in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. Subjects or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer twice a day on the body and scalp for up to 8 weeks. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated.
Detailed description
This is a multicenter, open-label, Phase 1 study in a total of 75 pediatric subjects, ages 2 to 11 years, inclusive, with mild or moderate plaque psoriasis.
The study will enroll sufficient subjects with plaque psoriasis and an ISGA score of mild to moderate (score of 2 or 3) at Baseline to ensure 50 evaluable subjects in a general use cohort.
In addition, a sufficient number of subjects with moderate plaque psoriasis will be enrolled to ensure 25 evaluable subjects in a 'maximum-use' cohort that have:
- At least 10% total BSA with some scalp involvement (15 evaluable subjects ages 7 to 11 years) or B. At least 3% total BSA with some scalp involvement (10 evaluable subjects ages 2 to 6 years). "Napkin" psoriasis (psoriasis in the diaper area) can be included in the BSA calculation for this age group.
Subjects or their caregivers will apply a thin layer of study product twice a day to the treatment areas for 8 weeks. Any new psoriatic lesions appearing in treatment areas during the treatment period should also be treated with study product. Safety assessments (adverse event and serious adverse event query) will occur at all study visits. Treatment effect assessments, urine calcium metabolism assessments, and application site tolerability assessments will be performed for all subjects at all in-clinic visits. A blood sample will be taken from all subjects at Screening for evaluation of pharmacodynamic (PD) and 2,5-OH vitamin D levels, an additional blood draw for PD parameters will be taken at Week 2 for the maximum-use cohort only. Blood sampling for pharmacokinetic (PK) measurements will be performed in the maximum-use cohort at Screening and Week 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcipotriene 0.005% Foam | Experimental | Drug: Calcipotriene 0.005% FoamFoam is a vitamin D3 analog (calcipotriene) foam 0.005%. It is applied twice a day for 8 weeks to psoriasis lesions (except the face). |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent
- For the maximum-use cohort:
- ISGA of 3 or higher at Screening (see Appendix 2). Ages 7 to 11 - at least 10% total BSA with some scalp involvement (See Appendix 1).
- Ages 2 to 6 - at least 3% total BSA (napkin psoriasis included) with some scalp involvement (See Appendix 1).
- -For the general use cohort, an ISGA score of 2 or 3 at Screening with no BSA minimum.
Key exclusion criteria (14 listed)
- Any inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis
- Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative, or pustular psoriasis
- Use of any topical treatments that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, vitamin D derivatives, coal tar, tazarotene, medicated shampoos, or anthralin, within 2 weeks prior to enrollment
- Use of nonbiologic systemic antipsoriatic therapy (eg, corticosteroids, psoralen, retinoids, methotrexate, cyclosporine, other immunosuppressive agents), biologic therapy (eg, adalimumab, etanercept, golimumab, infliximab, ustekinumab), or phototherapy (eg, psoralen and ultraviolet A [PUVA], ultraviolet B [UVB]) within 4 weeks prior to enrollment
- Use of or need for initiation of any nonpsoriatic therapy that might affect psoriasis (including antimalarials, β-blockers, interferon, or lithium) within 4 weeks prior to enrollment
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 |
|---|---|---|
| Calcipotriene 0.005% FoamAlso: SoriluxAll treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face). | Drug | Calcipotriene 0.005% Foam |
Primary outcome
Evaluation of treatment effect and change in ISGA scores of body and scalp psoriasis (Safety and Tolerability)
Time frame: 56 weeks
To evaluate the safety and tolerability of calcipotriene foam, 0.005%, in pediatric subjects (ages 2 to 11 years, inclusive) with mild to moderate plaque psoriasis. An evaluation of treatment effect will include changes in ISGA scores of body and scalp psoriasis from baseline. Safety will be assessed based on vital signs, reported adverse events (AEs), use of concomitant medications, and application site tolerability assessments.
2 secondary outcomes
Plasma concentrations (trough) of calcipotriene
Time frame: 8 weeks
Pharmacodynamic effect
Time frame: 2 weeks
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 22 Jan 2019.
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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.
Stuart Mudge study director
Sponsor GmbH
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcipotriene 0.005% Foam in people with Psoriasis, run by Mayne Pharma International Pty Ltd at 36 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 5 inclusion and 14 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Evaluation of treatment effect and change in ISGA scores of body and scalp psoriasis (Safety and Tolerability) (time frame: 56 weeks). 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 22 Jan 2019.