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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%

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clobex Spray
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hamzavi Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clobex spray

Arm Description

Outcomes

Primary Outcome Measures

Subject Reported Target Lesion Severity Score.
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

Investigator Reported Target Lesion Severity Score
Investigator 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

Full Information

First Posted
June 26, 2013
Last Updated
September 7, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01893567
Brief Title
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Official Title
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clobex spray
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clobex Spray
Other Intervention Name(s)
Clobetasol propionate spray
Primary Outcome Measure Information:
Title
Subject Reported Target Lesion Severity Score.
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
Secondary Outcome Measure Information:
Title
Investigator Reported Target Lesion Severity Score
Description
Investigator 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fasahat Hamzavi, MD
Organizational Affiliation
Hamzavi Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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