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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%

Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis

Intervention: Clobex Spray (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Fasahat Hamzavi, MD, Principal Investigator, Affiliation: Hamzavi Dermatology

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Subject Reported Target Lesion Severity Score.

Secondary outcome:

Investigator Reported Effectiveness Scores

Subject Reported Effectiveness Scores

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Hamzavi Dermatology, Fort Gratiot, Michigan 48059, United States
Additional Information

Starting date: July 2013
Last updated: September 3, 2014

Page last updated: August 23, 2015

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