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

NCT00763555 | Completed Phase 2 Results

• 1 other identifier: RD.06.SPR.18119
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Psoriasis

Keywords

psoriasis; spray; calcitriol

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Success Rate 1 (SR1) at Week 8

  Success Rate 1 was defined as percentage of participants who achieved at least 2-grade improvement from Baseline on Global Severity Score (GSS) at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

  Week 8

• Percentage of Participants With Success Rate 2 (SR2) at Week 8

  Success Rate 2 was defined as percentage of participants who achieved "clear" or "almost clear" on GSS at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

  Week 8

• Change From Baseline in Dermatologic Sum Score (DSS) at Week 8

  DSS is the sum of all the individual score of evaluated target lesion that includes plaque elevation (abnormal thickness of the psoriasis lesion), erythema (abnormal redness of the skin), and scaling (shedding of the stratum corneum). Each individual parameters evaluated the affected area by using a 5-point scale ranging from 0 to 4, that is, 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe and 4 =Very severe, where higher score indicated worst condition. All missing values were imputed by last observation carried forward (LOCF). The total score of each parameter ranges from 0-12, where higher score indicated worst condition.

  Baseline, Week 8

• Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation

  Erythema (abnormal redness of skin) score is a 5-point scale: 0=None (No detectable erythema. Skin of normal color); 1=Mild (Slight pinkness present); 2=Moderate (Definite redness, easily recognized); 3=Severe (Intense redness) and 4=Severe (Very Intense redness). Scaling (shedding of stratum corneum) score is a 5- point scale: 0=None (No shedding); 1=Mild (Barely perceptible shedding, noticeable only on light scratching or rubbing); 2=Moderate (Obvious but not profuse shedding); 3=Severe (heavy scale production) and 4=Very severe (very thick scales). Plaque elevation (abnormal thickness of psoriasis lesion) score was a 5- point scale: 0=None (Normal skin thickness. No elevation of skin); 1=Mild (Barely perceptible elevation (by touching) of psoriasis plaques); 2=Moderate (Obvious elevation above normal skin level; moderate thickening); 3=Severe (definite thick elevation above normal skin level) and 4=Severe (Very thick elevation).

  Baseline, Week 8

Secondary Outcomes (12)

• Number of Participants With Adverse Events (AEs)

  up to Week 8

• Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score

  up to Week 8

• Change From Baseline in Calcitriol Plasma Levels

  Baseline, Week 8

• Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin

  Baseline, Week 8

• Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium

  Baseline, Week 8

Study Arms (2)

Calcitriol 3 mcg/g Spray

EXPERIMENTAL

Drug: CD 2027

Calcitriol Vehicle

PLACEBO COMPARATOR

Drug: Calcitriol Vehicle

Interventions

CD 2027 DRUG

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

Also known as: Calcitriol

Calcitriol 3 mcg/g Spray

Calcitriol Vehicle DRUG

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

Calcitriol Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (6)

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Stratica Medical

Edmonton, Alberta, T5K1X3, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M6L2, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B3Z7, Canada

Location

K. Papp Clinical Research, Inc.

Waterloo, Ontario, N2J1C4, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 23, 2022
• Results First Posted: August 23, 2022

Record last verified: 2022-04

Locations

CA (4); US (2)