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Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01563068
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mayne Pharma International Pty Ltd

Brief 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. The current study is a multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14 days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Calcipotriene 0.005% Foam Phase 1

Detailed Description:
This Phase 1 multicenter, open-label, repeat-dose study is designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene foam, 0.005%, applied topically to adolescent subjects with moderate plaque psoriasis (defined as a score of 3 on the Investigator's Static Global Assessment [ISGA]) involving a minimum of 10% body surface area (BSA) excluding the face and scalp, and a minimum of 20% scalp involvement. Subjects will be enrolled no more than 2 weeks after Screening. Approximately 30 eligible subjects, ages 12 to 16 years, inclusive, will be enrolled to ensure 20 completing subjects. Calcipotriene foam will be applied as a thin layer twice a day for 14 days and once on Day 15 on all treatment areas. Blood samples for the evaluation of albumin adjusted calcium, intact parathyroid hormone (iPTH), alkaline phosphatase, magnesium, and phosphorus will be taken at Screening and on Day 1 (before the first dose), Day 15 (3 to 9 hours after dosing), and on Day 22 if the results from Day 15 show any abnormalities. Serum 25-OH vitamin D concentrations will be evaluated on Day 1 (before the first dose). Safety and tolerability will be evaluated throughout the treatment period and a 7 day follow-up period. Blood samples for pharmacokinetic (PK) evaluation will be collected on Days 1 and 15. Urine samples for evaluation of calcium/creatinine ratio will be collected before dosing on Days 1 and 15.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Calcipotriene Foam, 0.005%, Applied Under Maximal-Use Conditions in Adolescent Subjects (Ages 12 to 16 Years) With Plaque Psoriasis
Actual Study Start Date : April 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Calcipotriene Foam
Calcipotriene foam 0.005% administered under maximal-use conditions to adolescent patients with plaque psoriasis
Drug: Calcipotriene 0.005% Foam
Topical application applied twice a day for 15 days
Other Name: Sorilux



Primary Outcome Measures :
  1. Effect of calcium metabolism [ Time Frame: Up to 3 Weeks ]
    determine albumin-adjusted calcium, iPTH, alkaline phosphatase, and phosphorus


Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: predose, 1,2,3,4,6 hours postdose ]
    Area Under Curve (AUC)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects, ages 12 to 16 years, inclusive, at the time of consent.
  2. Plaque psoriasis involving 10% body surface area (excluding the scalp and face).
  3. 20% scalp involvement (excluding the body and face).
  4. Clinical diagnosis of mild to moderate plaque psoriasis, as defined by an ISGA score at Screening of 3 on a scale of 0 to 4.
  5. The ability and willingness of the subject and the subject's primary caregiver to follow all study procedures, attend all scheduled visits, and successfully complete the study.

5. The subject's parent(s) or legal guardian must have the ability to understand and sign a written informed consent form and a Health Insurance Portability and Accountability Act (HIPAA) authorization form, which must be obtained prior to participation in this study. The HIPAA authorization may be incorporated in the informed consent form. Also, the subject's assent must be obtained and documented.

Exclusion Criteria:

  1. Any inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (eg, atopic dermatitis, contact dermatitis, tinea corporis).
  2. Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative, or pustular psoriasis.
  3. Use of any topical product (including sunscreen, creams, ointments, lotions, and powders) applied on or near the treatment area within 48 hours prior to enrollment.
  4. Use of topical treatments that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, vitamin D derivatives, coal tar, tazarotene, or anthralin, medicated shampoos within 2 weeks prior to enrollment.
  5. Use of nonbiologic systemic antipsoriatic therapy (eg, corticosteroids, retinoids, methotrexate, cyclosporine, other immunosuppressive agents), biologic therapy (eg, alefacept, etanercept, efalizumab), or phototherapy (eg, ultraviolet A, psoralen and ultraviolet A, ultraviolet B) within 4 weeks prior to enrollment.
  6. Use or need for initiation of any nonpsoriatic therapy that might affect psoriasis (including antimalarials, adrenergic receptor blockers, interferon, or lithium) within 4 weeks prior to enrollment.
  7. 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.
  8. Known difficult venous access beyond that expected for subject age.
  9. Any serious skin disorder or any chronic medical condition that is not well controlled.
  10. Positive urine drug screen result for alcohol, cotinine, or drugs of abuse at the time of Screening.
  11. 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.
  12. Current drug or alcohol abuse.
  13. History of hypersensitivity, known allergy, or other adverse reaction to calcipotriene or other vitamin D analogs or to any component of the study product.
  14. Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
  15. Use of any investigational therapy within 4 weeks prior to enrollment.
  16. Pregnant, breastfeeding, or sexually active female subjects of childbearing potential (after menarche) who are not practicing an acceptable method of contraception. Acceptable methods of contraception include one of the following highly effective methods of contraception (ie, Pearl Index <1.0%): complete abstinence from intercourse or 2 forms of barrier contraception (diaphragm plus spermicide for females, condom plus spermicide for males), or systemic contraceptives (combined or progesterone only) used in combination with a condom. The subject must agree to use an acceptable method of contraception from 2 weeks prior to administration of study product, throughout the study, and for 28 days after completion or premature discontinuation from the study.
  17. Current immunosuppression.
  18. Albumin-adjusted serum calcium at Screening that is outside the normal reference range.
  19. Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

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): NCT01563068


Locations
United States, California
Investigational Site
San Diego, California, United States, 92123
United States, Florida
Investigational Site
Ormond Beach, Florida, United States, 32174
Investigational Site
Tampa, Florida, United States, 33609
United States, Georgia
Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
Investigational Site
Chicago, Illinois, United States, 60611
United States, Indiana
Investigational Site
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Investigational Site
Louisville, Kentucky, United States, 40217
United States, Pennsylvania
Investigational Site
Philadelphia, Pennsylvania, United States, 19103
United States, Texas
Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mayne Pharma International Pty Ltd
GlaxoSmithKline

Responsible Party: Mayne Pharma International Pty Ltd
ClinicalTrials.gov Identifier: NCT01563068     History of Changes
Other Study ID Numbers: STF115750
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

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

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

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