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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. Identifier: NCT01893567
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : July 11, 2014
Last Update Posted : September 9, 2014
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Clobex Spray Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Study Start Date : July 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Clobex spray Drug: Clobex Spray
Other Name: Clobetasol propionate spray

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Investigator Reported Effectiveness Scores [ Time Frame: 2 weeks ]
  2. Subject Reported Effectiveness Scores [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01893567

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United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Sponsors and Collaborators
Galderma Laboratories, L.P.
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Principal Investigator: Fasahat Hamzavi, MD Hamzavi Dermatology
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Responsible Party: Galderma Laboratories, L.P. Identifier: NCT01893567    
Other Study ID Numbers: GLI.04.SPR.US10243
First Posted: July 9, 2013    Key Record Dates
Results First Posted: July 11, 2014
Last Update Posted: September 9, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Erythema Multiforme
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Vesiculobullous
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs