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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01893567
Other study ID # GLI.04.SPR.US10243
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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