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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%

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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.

Tracking Information
First Submitted Date  ICMJE June 26, 2013
First Posted Date  ICMJE July 9, 2013
Results First Submitted Date  ICMJE June 11, 2014
Results First Posted Date  ICMJE July 11, 2014
Last Update Posted Date September 9, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2014)
Subject Reported Target Lesion Severity Score. [ Time Frame: 2 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Relationship Between Digital Photographs of a Target Lesion and Investigator an Subject Reported Severity Scores [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • Investigator Reported Effectiveness Scores [ Time Frame: 2 weeks ]
  • Subject Reported Effectiveness Scores [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Official Title  ICMJE Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Brief Summary The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE Drug: Clobex Spray
Other Name: Clobetasol propionate spray
Study Arms  ICMJE Experimental: Clobex spray
Intervention: Drug: Clobex Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2013)
28
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
40
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects 18 years of age or older.
  • Subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray.
  • Subjects with a target lesion of at least 1 cm x 1 cm
  • Subjects who agree to be photographed at each visit

Exclusion Criteria:

  • Subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study.
  • Subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink.
  • Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial.
  • Subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any Galderma employee.
  • Subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893567
Other Study ID Numbers  ICMJE GLI.04.SPR.US10243
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fasahat Hamzavi, MD Hamzavi Dermatology
PRS Account Galderma Laboratories, L.P.
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP