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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.

This study is currently recruiting participants.
Verified May 2017 by Mayne Pharma International Pty Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582932
First Posted: April 23, 2012
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mayne Pharma International Pty Ltd
  Purpose
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.

Condition Intervention Phase
Psoriasis Drug: Calcipotriene 0.005% Foam Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mayne Pharma International Pty Ltd:

Primary Outcome Measures:
  • 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 [ Time Frame: 8 weeks ]
  • 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. [ Time Frame: 2 weeks ]

Other Outcome Measures:
  • Tabulation of Concomitant Medications [ Time Frame: 8 weeks ]
  • Extent of Calcipotriene exposure determined by amount of product used [ Time Frame: 8 weeks ]
  • Compliance with Study Medication Assessment [ Time Frame: 8 weeks ]
  • Adverse Event tabulation by severity, intensity, serious/non-serious, and treatment-emergent/non-TEAE [ Time Frame: 8 weeks ]
  • Vital Sign tabulations [ Time Frame: 8 weeks ]
    averages across patients, visits, significant changes

  • Clinical Laboratory Evaluations [ Time Frame: 8 weeks ]
    Shifts in lab parameters during treatment, clinically significant parameters

  • Investigator Assessment of Tolerability - Erythema [ Time Frame: 8 weeks ]
    Change in assessment from baseline to EOT

  • Subject Assessment of Tolerability- Pain [ Time Frame: 8 weeks ]
    Change in assessment from baseline to EOT


Estimated Enrollment: 75
Study Start Date: April 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcipotriene Foam
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).
Drug: Calcipotriene 0.005% Foam
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).
Other Name: Sorilux

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:

A. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

A. 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 (ie, psoriasis in the diaper area) can be included in the BSA calculation for this age group.

Key Inclusion Criteria:

  • Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent
  • For the maximum-use cohort:

A. 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:

  • 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582932


Contacts
Contact: Karthi K Natarajan, MPH 984-242-1347 karthi.natarajan@maynepharma.com

  Show 27 Study Locations
Sponsors and Collaborators
Mayne Pharma International Pty Ltd
GlaxoSmithKline
  More Information

Responsible Party: Mayne Pharma International Pty Ltd
ClinicalTrials.gov Identifier: NCT01582932     History of Changes
Other Study ID Numbers: STF115469
First Submitted: March 29, 2012
First Posted: April 23, 2012
Last Update Posted: May 19, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Mayne Pharma International Pty Ltd:
plaque psoriasis
pediatric
mild
moderate

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Calcitriol
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents