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

NCT01563068 | Completed Phase 1 FDA Drug

• 1 other identifier: STF115750
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 9

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

Conditions

Psoriasis

Keywords

plaque psoriasis; pediatric; adolescent

Outcome Measures

Primary Outcomes (1)

• Effect of calcium metabolism

  determine albumin-adjusted calcium, iPTH, alkaline phosphatase, and phosphorus

  Up to 3 Weeks

Secondary Outcomes (1)

• Pharmacokinetics

  predose, 1,2,3,4,6 hours postdose

Study Arms (1)

Calcipotriene Foam

EXPERIMENTAL

Calcipotriene foam 0.005% administered under maximal-use conditions to adolescent patients with plaque psoriasis

Drug: Calcipotriene 0.005% Foam

Interventions

Calcipotriene 0.005% Foam DRUG

Topical application applied twice a day for 15 days

Also known as: Sorilux

Calcipotriene Foam

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• % 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.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayne Pharma International Pty Ltd: lead
• GlaxoSmithKline: collaborator

Study Sites (9)

Investigational Site

San Diego, California, 92123, United States

Location

Investigational Site

Ormond Beach, Florida, 32174, United States

Location

Investigational Site

Tampa, Florida, 33609, United States

Location

Investigational Site

Marietta, Georgia, 30060, United States

Location

Investigational Site

Chicago, Illinois, 60611, United States

Location

Investigational Site

Indianapolis, Indiana, 46256, United States

Location

Investigational Site

Louisville, Kentucky, 40217, United States

Location

Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

Investigational Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 26, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (9)