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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01893567
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 9.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: Clobex Spray	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clobex spray	Drug: Clobex Spray; Other Names: Clobetasol propionate spray

Outcome Measures

Primary Outcome Measures

1. 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

1. Investigator Reported Effectiveness Scores [2 weeks]

2. Subject Reported Effectiveness Scores [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamzavi Dermatology	Fort Gratiot	Michigan	United States	48059

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Fasahat Hamzavi, MD, Hamzavi Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01893567
• Other Study ID Numbers: GLI.04.SPR.US10243
• First Posted: Jul 9, 2013
• Last Update Posted: Sep 9, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Psoriasis; Erythema Multiforme; Clobetasol

Study Results

Participant Flow

Arm/Group Title	Clobex Spray
Arm/Group Description	Clobex Spray
Period Title: Overall Study
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Clobex Spray
Arm/Group Description	Clobex Spray
Overall Participants	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (12.8)
Sex: Female, Male (Count of Participants)
Female	18 64.3%
Male	10 35.7%
Region of Enrollment (participants) [Number]
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	Subject Reported Target Lesion Severity Score.
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clobex Spray
Arm/Group Description	Clobex Spray
Measure Participants	28
Mean (Standard Deviation) [units on a scale]	4.0 (2.5)

2. Secondary Outcome

Title	Investigator Reported Effectiveness Scores
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Subject Reported Effectiveness Scores
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Clobex Spray
Arm/Group Description	Clobex Spray
All Cause Mortality
	Clobex Spray
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Clobex Spray
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	Clobex Spray
	Affected / at Risk (%)	# Events
Total	4/28 (14.3%)
Musculoskeletal and connective tissue disorders
Joint swelling	1/28 (3.6%)	1
Skin and subcutaneous tissue disorders
Erythema	1/28 (3.6%)	1
Pruritus	1/28 (3.6%)	1
Skin exfoliation	1/28 (3.6%)	1
Skin plaque	1/28 (3.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.