- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01563068
Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92123
- Investigational Site
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Florida
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Ormond Beach, Florida, United States, 32174
- Investigational Site
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Tampa, Florida, United States, 33609
- Investigational Site
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Georgia
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Marietta, Georgia, United States, 30060
- Investigational Site
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Illinois
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Chicago, Illinois, United States, 60611
- Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46256
- Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40217
- Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Investigational Site
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Texas
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Houston, Texas, United States, 77030
- Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subjects, ages 12 to 16 years, inclusive, at the time of consent.
- Plaque psoriasis involving 10% body surface area (excluding the scalp and face).
- 20% scalp involvement (excluding the body and face).
- 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.
- 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:
- Any inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (eg, atopic dermatitis, contact dermatitis, tinea corporis).
- Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- 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.
- 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.
- 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.
- 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.
- 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.
- Any serious skin disorder or any chronic medical condition that is not well controlled.
- Positive urine drug screen result for alcohol, cotinine, or drugs of abuse at the time of Screening.
- 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.
- Current drug or alcohol abuse.
- 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, 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.
- Current immunosuppression.
- Albumin-adjusted serum calcium at Screening that is outside the normal reference range.
- Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Calcipotriene Foam
Calcipotriene foam 0.005% administered under maximal-use conditions to adolescent patients with plaque psoriasis
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Topical application applied twice a day for 15 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of calcium metabolism
Time Frame: Up to 3 Weeks
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determine albumin-adjusted calcium, iPTH, alkaline phosphatase, and phosphorus
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Up to 3 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics
Time Frame: predose, 1,2,3,4,6 hours postdose
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Area Under Curve (AUC)
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predose, 1,2,3,4,6 hours postdose
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STF115750
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Leon Kircik, M.D.Stiefel, a GSK CompanyCompleted
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LEO PharmaCompleted
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