Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

A multicenter open label uncontrolled study of the long term safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 26 weeks in pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis - LTS and efficacy study of calcitriol 3 mcg/g ointment in pediatric subjects with plaque psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000710-53-DE

Enrollment

100

Registered

2014-10-28

Start date

2014-12-19

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Vectical® (calcitriol) ointment 3 mcg/g Product Name: Calcitriol Product Code: CD2027 Pharmaceutical Form: Ointment INN or Proposed INN: Calcitriol CAS Number: 32222-06-03 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female 2 to 16 years and 11 months at Screening. - The subject has a clinical diagnosis of stable mild to moderate plaque type psoriasis. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Subjects with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis or active infection (i.e., an infection associated with fever, swollen lymph nodes, and/or signs of localized inflammation of tissue and/or joints). - Subject has hypercalcemia (serum albumin-adjusted calcium level above the upper normal range) at Screening. - Subjects with known or suspected disorders of calcium metabolism.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Ct (pre dose plasma concentration) ;Timepoint(s) of evaluation of this end point: at each visit	—

Primary

Measure	Time frame
Main Objective: To evaluate the safety of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with plaque psoriasis.;Secondary Objective: As a secondary objective, calcitriol plasma concentrations will be assessed at several time points throughout the study duration in a subset of children 2 to 6 years and 11 months old.;Primary end point(s): Efficacy endpoints: - Percentage of subjects with an IGA Score of 0 (clear) or 1 (almost clear) - Change from Baseline in Pruritus - Change from Baseline in % BSA Safety endpoints: - Serum albumin-adjusted calcium, urine calcium:creatinine ratio, phosphorus, and PTH - Adverse events;Timepoint(s) of evaluation of this end point: At each visit	—

Measure

Time frame

Main Objective: To evaluate the safety of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with plaque psoriasis.;Secondary Objective: As a secondary objective, calcitriol plasma concentrations will be assessed at several time points throughout the study duration in a subset of children 2 to 6 years and 11 months old.;Primary end point(s): Efficacy endpoints: - Percentage of subjects with an IGA Score of 0 (clear) or 1 (almost clear) - Change from Baseline in Pruritus - Change from Baseline in % BSA Safety endpoints: - Serum albumin-adjusted calcium, urine calcium:creatinine ratio, phosphorus, and PTH - Adverse events;Timepoint(s) of evaluation of this end point: At each visit

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Countries

Belgium, Canada, Germany, Hungary, Italy, United States

Contacts

Public ContactCTA Coordinator

GALDERMA R&D, SNC

cta.coordinator@galderma.com+33(0)493-95-70-85

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026