A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasis

A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasis - Safety 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

EUCTR2014-001744-38-DE

Enrollment

300

Registered

2014-10-28

Start date

2015-03-25

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Psoriasis

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 pediatric subjects (2 to 12 years of age, inclusive) at Screening. - Clinical diagnosis of stable plaque psoriasis with an IGA score of 2 or 3 at Screening and Baseline. Are the trial subjects under 18? yes Number of subjects for this age range: 300 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, 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) Note: allergic or vasomotor rhinitis is not exclusionary. - 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

Primary

Measure	Time frame
Main Objective: To compare the safety of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding the face and scalp). To evaluate the effect of twice daily use of calcitriol 3 mcg/g ointment versus vehicle on calcium metabolism in children aged 2 to 12 years with plaque psoriasis (excluding face and scalp). To compare the efficacy of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding face and scalp).;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: At each visit;Primary end point(s): Primary Efficacy Endpoints/Variables The primary endpoint variable is success rate defined as the percentage of subjects with an IGA of 0 (clear) or 1 (almost clear), and at least a 2 grade improvement from baseline. Safety endpoints: - Serum albumin-adjusted calcium, urine calcium: creatinine ratio, phosphorus, and PTH	—

Measure

Time frame

Main Objective: To compare the safety of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding the face and scalp). To evaluate the effect of twice daily use of calcitriol 3 mcg/g ointment versus vehicle on calcium metabolism in children aged 2 to 12 years with plaque psoriasis (excluding face and scalp). To compare the efficacy of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding face and scalp).;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: At each visit;Primary end point(s): Primary Efficacy Endpoints/Variables The primary endpoint variable is success rate defined as the percentage of subjects with an IGA of 0 (clear) or 1 (almost clear), and at least a 2 grade improvement from baseline. Safety endpoints: - Serum albumin-adjusted calcium, urine calcium: creatinine ratio, phosphorus, and PTH

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary Efficacy Endpoints/Variables - Change from Baseline in Pruritus - Change from Baseline in %BSA;Timepoint(s) of evaluation of this end point: At each visits	—

Countries

Belgium, Canada, Germany, Hungary, Italy, Spain, 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