Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcitriol 3 mcg/g Spray

Group Type EXPERIMENTAL

CD 2027

Intervention Type DRUG

Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

Calcitriol Vehicle

Group Type PLACEBO_COMPARATOR

Calcitriol Vehicle

Intervention Type DRUG

Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

Interventions

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CD 2027

Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

Intervention Type DRUG

Calcitriol Vehicle

Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

Intervention Type DRUG

Other Intervention Names

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Calcitriol

Eligibility Criteria

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Inclusion Criteria

* Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area (BSA) involved excluding the scalp, with a Global Severity Score of at least 3 (moderate) at Screening
* Participant presents with a representative target lesion that is at least 16 cm² in area, is located on the non-bony areas of the skin, has a Scaling Score up to 2 (moderate), has a DSS of at least 4