A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

Galderma

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: Calcitriol 3mcg/g

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419666

RD.06.SPR.18102

Details and patient eligibility

About

This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.

Enrollment: 25 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic plaque psoriasis
• 10 - 35% BSA of involved skin
• Age 12 - 17

Exclusion criteria

• Other type of psoriasis (other than plaque)
• Significant abnormal lab findings
• Vit D insufficiency

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Calcitriol 3mcg/g

Experimental group

Description:

Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.

Treatment:

Drug: Calcitriol 3mcg/g