Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis

NCT01582932 | Completed Phase 1 FDA Drug

• 1 other identifier: STF115469
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 36

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 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.

Conditions

Psoriasis

Keywords

plaque psoriasis; pediatric; mild; moderate

Outcome Measures

Primary Outcomes (1)

• 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.

  56 weeks

Secondary Outcomes (2)

• Plasma concentrations (trough) of calcipotriene

  8 weeks

• Pharmacodynamic effect

  2 weeks

Study Arms (1)

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).

Drug: Calcipotriene 0.005% Foam

Interventions

Calcipotriene 0.005% Foam DRUG

All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).

Also known as: Sorilux

Calcipotriene 0.005% Foam

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (36)

Investigational Site

Birmingham, Alabama, 35233, United States

Location

Investigational Site

Rogers, Arkansas, 72758, United States

Location

Investigational Site

Encino, California, 91436, United States

Location

Unknown Facility

Fountain Valley, California, 92708, United States

Location

Unknown Facility

Santa Ana, California, 92705, United States

Location

Unknown Facility

Sherman Oaks, California, 91403, United States

Location

Investigational Site

Hollywood, Florida, 33021, United States

Location

Investigational Site

Jacksonville, Florida, 32204, United States

Location

Unknown Facility

Miami, Florida, 33014, United States

Location

Investigational Site

Miami, Florida, 33136, United States

Location

Investigational Site

Tampa, Florida, 33690, United States

Location

Investigational Site

Alpharetta, Georgia, 30022, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Investigational Site

Marietta, Georgia, 30060, United States

Location

Investigational Site

Sandy Springs, Georgia, 30328, United States

Location

Investigational Site

Chicago, Illinois, 60614, United States

Location

Investigational Site

Plainfield, Indiana, 46188, United States

Location

Unknown Facility

Brighton, Massachusetts, 02135, United States

Location

Investigational Site

Farmington Hills, Michigan, 48334, United States

Location

Unknown Facility

Saint Joseph, Missouri, 64506, United States

Location

Investigational Site

St Louis, Missouri, 63104, United States

Location

Investigational Site

St Louis, Missouri, 63117, United States

Location

Investigational Site

New York, New York, 10467, United States

Location

Investigational Site

Chapel Hill, North Carolina, 27516, United States

Location

Investigational Site

Winston-Salem, North Carolina, 27157, United States

Location

Investigational Site

Portland, Oregon, 97239, United States

Location

Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19109, United States

Location

Investigational Site

Austin, Texas, 78723, United States

Location

Investigational Site

Houston, Texas, 77030, United States

Location

Investigational Site

Houston, Texas, 77056, United States

Location

Unknown Facility

San Antonio, Texas, 78218, United States

Location

Investigational Site

Salt Lake City, Utah, 84132-2409, United States

Location

Investigational Site

Norfolk, Virginia, 23502, United States

Location

Investigational Site

Spokane, Washington, 99202, United States

Location

Investigational Site

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Psoriasis; Lymphoma, Follicular

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Stuart Mudge

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 23, 2012
• Study Start: April 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

US (36)