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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893567
• Other study ID #: GLI.04.SPR.US10243
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: August 2018
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erythema Multiforme
• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Clobex Spray

Locations

Country	Name	City	State
United States	Hamzavi Dermatology	Fort Gratiot	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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	2 weeks