Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00437216
First received: February 16, 2007
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.


Condition Intervention Phase
Psoriasis
Drug: Clobetasol Propionate, 0.05%
Drug: Clobetasol propionate, 0.05% Spray
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Phase 4 Open-Label Multicenter Community-Based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Efficacy - Change in Target Plaque Severity rating [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy - Self-Assessment of Quality of Life, Subject satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety - Evaluation of adverse events and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2488
Study Start Date: February 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
Drug: Clobetasol Propionate, 0.05%
Apply twice daily for 2 or 4 weeks as monotherapy
Other Name: Clobex® Spray, 0.05%
2
Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment
Drug: Clobetasol propionate, 0.05% Spray
Apply twice daily for 2 or 4 weeks as add-on therapy
Other Name: Clobex® Spray, 0.05%

Detailed Description:

Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community Sample

Criteria

Inclusion Criteria:

  • Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
  • At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
  • History of stable plaque psoriasis of greater than or equal to 3 months

Exclusion Criteria:

  • Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
  • Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
  • Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437216

Locations
United States, New Jersey
DHC Dimensional HealthCare, Inc. (Clinical Research Organization)
Cedar Knolls, New Jersey, United States, 76117
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, LP
  More Information

No publications provided

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00437216     History of Changes
Other Study ID Numbers: US10029
Study First Received: February 16, 2007
Last Updated: March 27, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014