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A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845481
First Posted: February 18, 2009
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LEO Pharma
  Purpose
The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

Condition Intervention Phase
Psoriasis Vulgaris Drug: Daivobet® ointment Drug: Betnovat® ointment Drug: Diprosalic ointment Drug: Dermovat ointment Drug: Elocon ointment Drug: Daivobet® ointment vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Official Title: A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment [ Time Frame: Baseline and 3 weeks ]
    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  • The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment [ Time Frame: Baseline and 3 weeks ]
    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  • The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment [ Time Frame: Baseline and 3 weeks ]
    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  • The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle [ Time Frame: Baseline and 3 weeks ]
    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  • The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment [ Time Frame: Baseline and 3 weeks ]
    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  • The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment [ Time Frame: Baseline and 3 weeks ]
    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)


Enrollment: 24
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: all patients apply all products Drug: Daivobet® ointment
Once daily application 6 days a week for 3 weeks
Drug: Betnovat® ointment
Once daily application 6 days a week for 3 weeks
Drug: Diprosalic ointment
Once daily application 6 days a week for 3 weeks
Drug: Dermovat ointment
Once daily application 6 days a week for 3 weeks
Drug: Elocon ointment
Once daily application 6 days a week for 3 weeks
Drug: Daivobet® ointment vehicle
Once daily application 6 days a week for 3 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (in summary)

  • Subjects having understood and signed an informed consent form
  • All skin types
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
  • Subjects willing and able to follow all the study procedures and complete the whole study
  • Subjects affiliated to social security system

Exclusion Criteria: (in summary)

  • Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
  • Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
  • Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
  • Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
  • Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
  • Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845481


Locations
France
LEO Pharma site
St Quentin Yvelines Cedex, France, 78054
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Director, International Clinical Development, MD LEO Pharma
  More Information

Additional Information:
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00845481     History of Changes
Other Study ID Numbers: PLQ-002
First Submitted: February 16, 2009
First Posted: February 18, 2009
Results First Submitted: January 13, 2011
Results First Posted: March 8, 2011
Last Update Posted: April 14, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents