Clinical trial · Interventional
Evaluate Safety and Tolerability of Calcipotriene Foam 0.005% in Pediatric Subjects With Mild/Moderate Plaque Psoriasis
A Multicenter, Open-label, Phase 1 Study of the Safety, Tolerability, Systemic Exposure, Pharmacodynamics, and Treatment Effect of Calcipotriene Foam, 0.005%, in Pediatric Subjects (Ages 2 to 11 Years) With Plaque Psoriasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcipotriene 0.005% Foam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Calcipotriene 0.005% Foam
- description
- 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).
- interventionNames
- Drug: Calcipotriene 0.005% Foam
Primary outcomes (1)
- measure
- Evaluation of treatment effect and change in ISGA scores of body and scalp psoriasis (Safety and Tolerability)
- timeFrame
- 56 weeks
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 11 Years
Show eligibility criteria text
A. At least 10% total BSA with some scalp involvement (15 evaluable subjects ages 7 to 11 years) or B. At least 3% total BSA with some scalp involvement (10 evaluable subjects ages 2 to 6 years). "Napkin" psoriasis (ie, psoriasis in the diaper area) can be included in the BSA calculation for this age group. Key Inclusion Criteria: * 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. Key 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 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
References
Publications (0)
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