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OpenTrials
Completed

NCT Number: NCT00658788

Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Therapeutics Clinical Research, San Diego, California, United States

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About this study

Same as above.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
  • Overall Disease Severity of at least 3 (moderate)

Exclusion criteria

  • Surface area involvement too large (>20% BSA)
  • Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas

Treatment and study plan

clobetasol propionate spray 0.05%

Drug

clobetasol propionate spray, 0.05%, applied topically twice daily

Other names: Clobex® Spray 0.05%

calcitriol ointment

Drug

calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Primary outcomes

  1. Overall Disease Severity Success (ODS)

    Time frame: 8 and 12 weeks

    Success was defined as a one-grade improvement in ODS from baseline.

Secondary outcomes

  1. Global Improvement Score

    Time frame: 2, 4, 8 and 12 weeks

  2. Signs of Psoriasis - Erythema

    Time frame: 2, 4, 8 and 12 weeks

  3. Signs of Psoriasis - Scaling

    Time frame: 2, 4, 8 and 12 weeks

  4. Signs of Psoriasis - Plaque Elevation

    Time frame: 2, 4, 8 and 12 weeks

  5. Percent Change From Baseline in Body Surface Area (% BSA) Affected

    Time frame: 2, 4, 8 and 12 weeks

  6. Overall Disease Severity

    Time frame: 2, 4, 8 and 12 weeks

  7. Tolerability Assessment - Pruritus

    Time frame: Baseline, 2, 4, 8 and 12 weeks

  8. Tolerability Assessment - Telangiectasias

    Time frame: Baseline, 2, 4, 8 and 12 weeks

  9. Tolerability Assessment - Stinging/ Burning

    Time frame: Baseline, 2, 4, 8 and 12 weeks

  10. Tolerability Assessment - Skin Atrophy

    Time frame: Baseline, 2, 4, 8 and 12 weeks

  11. Tolerability Assessment - Folliculitis

    Time frame: Baseline, 2, 4, 8 and 12 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2008
Registry last updated
Aug 23, 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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