Last updated: 11/03/2018 18:08:58
This product has been transferred to Mayne Pharmaceuticals. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety, Efficacy, Systemic Exposure, and Pharmacodynamics of Calcipotriene Foam, 0.005%, Versus Vehicle Foam in Pediatric Subjects (Ages 2 to 11 Years) with Plaque Psoriasis
GSK study ID
115469
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety, Efficacy, Systemic Exposure, and Pharmacodynamics of Calcipotriene Foam, 0.005%, Versus Vehicle Foam in Pediatric Subjects (Ages 2 to 11 Years) with Plaque Psoriasis
Trial description: 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 comparing calcipotriene foam, 0.005% with vehicle foam 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
treatment success
Timeframe: week 8
Secondary outcomes:
erythema
Timeframe: week 8
scaling
Timeframe: week 8
plaque thickness
Timeframe: week 8
Interventions:
Enrollment:
180
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Psoriasis
Product
calcipotriol
Collaborators
Not applicable
Study date(s)
April 2013 to Invalid Date
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
2 - 11 Year
Accepts healthy volunteers
none
- Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent
- Clinical diagnosis of mild to moderate plaque psoriasis, as defined by body ISGA score of 2 or 3 on a scale of 0 to 4.
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female subjects, ages 2 to 11 years, inclusive, at the time of consent -Clinical diagnosis of mild to moderate plaque psoriasis, as defined by body ISGA score of 2 or 3 on a scale of 0 to 4. -Mild to moderate plaque psoriasis involving at least 5% BSA and at least 5% scalp involvement (excluding the face). -Identification of a target lesion (>2 cm2) on the trunk or extremities with a score of 2 or 3 on a 0 to 5 scale for erythema, scaling, and plaque thickness
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 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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