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

Galderma

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Calcitriol Vehicle; Drug: CD 2027

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763555

RD.06.SPR.18119

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Other type of psoriasis (other than plaque)
• Significant abnormal lab findings
• Hypercalcemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Calcitriol 3 mcg/g Spray

Experimental group

Treatment:

Drug: CD 2027

Calcitriol Vehicle

Placebo Comparator group

Treatment:

Drug: Calcitriol Vehicle