Phase 4 N=19 Randomized Quadruple-blind Treatment

Plaque Psoriasis Study in Pediatric Subjects

Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT02186665 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Success of Investigator's Global Assessment (IGA) — 3; 7 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: calcitriol ointment (Drug); placebo comparator (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Success of Investigator's Global Assessment (IGA)	3; 7	—

Summary

The purpose of this study is to compare the safety, efficacy and calcium metabolism 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.

Eligibility Criteria

Inclusion Criteria

Male or female 2 to 12 years of age
Clinical diagnosis of stable mild to moderate plaque psoriasis

Exclusion Criteria

Other forms of psoriasis
Hypercalcemia
Past history of kidney stones
Vitamin D deficiency
Other concomitant dermatological disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02186665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.