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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
History of Changes
  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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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
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 May 16, 2013