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

Psoriasis Clinical Trial

Official title:

A Multicenter, Randomized, Vehicle-controlled, Efficacy and Safety Study of CD2027 3µg/g Oily Spray Applied Twice Daily for 8 Weeks in Subjects With Plaque-type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763555
• Other study ID #: RD.06.SPR.18119
• Status: Completed
• Phase: Phase 2
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CD 2027
Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.
• Calcitriol Vehicle
Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

Locations

Country	Name	City	State
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Stratica Medical	Edmonton	Alberta
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	K. Papp Clinical Research, Inc.	Waterloo	Ontario
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Tennessee Clinical Research Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of Participants With Adverse Events (AEs)	AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	up to Week 8
Secondary	Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score	Local tolerability skin assessments were performed by the investigator and based on 5-point scale which ranges from 0 to 4. 0 = none (no evidence of local intolerance); 1=mild (minimal erythema and/or edema, slight glazed appearance); 2 = moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology); 3 = severe (erythema, edema glazing with fissures, few vesicles or papules) and 4 = very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions). Higher grades indicated worsening of condition. Percentage of participants with increase in score by Week 8 from baseline has been presented here, where the row titles indicate participant's new scores by Week 8.	up to Week 8
Secondary	Change From Baseline in Calcitriol Plasma Levels	Change from baseline in calcitriol plasma levels were reported.	Baseline, Week 8
Secondary	Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin	Change from baseline in serum calcium homeostasis parameter (Albumin) were reported.	Baseline, Week 8
Secondary	Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium	Change from baseline in serum calcium homeostasis parameter (Albumin-adjusted calcium) were reported.	Baseline, Week 8
Secondary	Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium	Change from baseline in serum calcium homeostasis parameter (Calcium) were reported.	Baseline, Week 8
Secondary	Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus	Change from baseline in serum calcium homeostasis parameter (Phosphorus) were reported.	Baseline, Week 8
Secondary	Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact	Change from baseline in serum calcium homeostasis parameter (PTH intact) were reported.	Baseline, Week 8
Secondary	Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)	Change from baseline in Blood Chemistry: Alkaline Phosphatase, AST and ALT were reported.	Baseline, Week 8
Secondary	Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine	Change from baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, BUN and Creatinine were reported.	Baseline, Week 8
Secondary	Change From Baseline in Vital Sign Parameter: Heart Rate	Change from baseline in vital sign parameter: heart rate was reported.	Baseline, Week 8
Secondary	Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure	Change from baseline in vital sign parameter: Systolic Blood Pressure and Diastolic Blood Pressure was reported.	Baseline, Week 8