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

Phase 4

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Clobex Spray

• Registration Number: NCT01893567
• Lead Sponsor: Galderma R&D

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 available

Study Timeline

• Study First Submitted: 2013-06-26
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2014-06-11
• Results First Submitted QC: 2014-06-11
• Results First Posted: 2014-07-11
• Status Verified: 2018-08
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clobex spray	Clobex Spray	-

Primary Outcome Measures

Name	Time	Method
Subject Reported Target Lesion Severity Score.	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

Name	Time	Method
Investigator Reported Target Lesion Severity Score	2 weeks	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

Trial Locations

Locations (1)

Hamzavi Dermatology; 🇺🇸 Fort Gratiot, Michigan, United States