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

NCT01893567 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SPR.US10243
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Investigator Reported Target Lesion Severity Score

  2 weeks

Study Arms (1)

Clobex spray

EXPERIMENTAL

Drug: Clobex Spray

Interventions

Clobex Spray DRUG

Also known as: Clobetasol propionate spray

Clobex spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Results Point of Contact

• Title: Senior Clinical Project Manager
• Organization: Galderma Laboratories, L.P.

jay.mashburn@galderma.com

817-961-5000

Study Officials

• Fasahat Hamzavi, MD

  Hamzavi Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 9, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 27, 2022
• Results First Posted: July 11, 2014

Record last verified: 2018-08

Locations

US (1)