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Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893567
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : July 11, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Drug: Clobex Spray
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clobex Spray
Hide Arm/Group Description Clobex Spray
Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Clobex Spray
Hide Arm/Group Description Clobex Spray
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
55.2  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
18
  64.3%
Male
10
  35.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Subject Reported Target Lesion Severity Score.
Hide Description Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clobex Spray
Hide Arm/Group Description:
Clobex Spray
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (2.5)
2.Secondary Outcome
Title Investigator Reported Effectiveness Scores
Hide Description [Not Specified]
Time Frame 2 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Subject Reported Effectiveness Scores
Hide Description [Not Specified]
Time Frame 2 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clobex Spray
Hide Arm/Group Description Clobex Spray
All-Cause Mortality
Clobex Spray
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Clobex Spray
Affected / at Risk (%) # Events
Total   0/28 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clobex Spray
Affected / at Risk (%) # Events
Total   4/28 (14.29%)    
Musculoskeletal and connective tissue disorders   
Joint swelling  1/28 (3.57%)  1
Skin and subcutaneous tissue disorders   
Erythema  1/28 (3.57%)  1
Pruritus  1/28 (3.57%)  1
Skin exfoliation  1/28 (3.57%)  1
Skin plaque  1/28 (3.57%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Clinical Project Manager
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5000
EMail: jay.mashburn@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01893567    
Other Study ID Numbers: GLI.04.SPR.US10243
First Submitted: June 26, 2013
First Posted: July 9, 2013
Results First Submitted: June 11, 2014
Results First Posted: July 11, 2014
Last Update Posted: September 9, 2014