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

NCT ID: NCT01893567

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clobex spray

Group Type: EXPERIMENTAL

Clobex Spray

Intervention Type: DRUG

Interventions

Clobex Spray

Intervention Type: DRUG

Other Intervention Names

Clobetasol propionate spray

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fasahat Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Hamzavi Dermatology

Locations

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Countries

United States

Other Identifiers

GLI.04.SPR.US10243

Identifier Type: -

Identifier Source: org_study_id