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OpenTrials
Completed

NCT Number: NCT00437216

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

DHC Dimensional HealthCare, Inc. (Clinical Research Organization)

Cedar Knolls, New Jersey, 76117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clobetasol Propionate, 0.05%

Drug

Apply twice daily for 2 or 4 weeks as monotherapy

Other names: Clobex® Spray, 0.05%

Clobetasol propionate, 0.05% Spray

Drug

Apply twice daily for 2 or 4 weeks as add-on therapy

Other names: Clobex® Spray, 0.05%

Primary outcomes

  1. Efficacy - Change in Target Plaque Severity rating

    Time frame: 4 weeks

Secondary outcomes

  1. Efficacy - Self-Assessment of Quality of Life, Subject satisfaction

    Time frame: 4 weeks

  2. Safety - Evaluation of adverse events and tolerability

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 19, 2007
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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