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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00845481
First received: February 16, 2009
Last updated: December 12, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00845481     History of Changes
Other Study ID Numbers: PLQ-002
Study First Received: February 16, 2009
Results First Received: January 13, 2011
Last Updated: December 12, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014