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A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
This study is currently recruiting participants.
Verified by LEO Pharma, April 2009
First Received: April 2, 2009   Last Updated: April 16, 2009   History of Changes
Sponsored by: LEO Pharma
Information provided by: LEO Pharma
ClinicalTrials.gov Identifier: NCT00875277
  Purpose

The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: LEO 29102 cream and combination products
Phase II

MedlinePlus related topics: Psoriasis
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Total Clinical Score of the clinical symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical scores, lesions thickness, histology and immunohistochemistry measurements [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: LEO 29102 cream and combination products
    Once daily application 6 days a week for 4 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875277

Contacts
Contact: Patrice Facy, PhD +33 1 3014 4067 patrice.facy@leo-pharma.com
Contact: Vibeke Hoffmann, MSc +45 44 94 58 88 ext 2450 vibeke.hoffmann@leo-pharma.com

Locations
France
LEO Pharma site Recruiting
St Quentin Yvelines Cedex, France
Contact: Patrice Facy, PhD     +33 1 3014 4067     patrice.facy@leo-pharma.com    
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Director, International Clinical Development, MD LEO Pharma
  More Information

No publications provided

Responsible Party: LEO Pharma ( Patrice Facy, International Clinical Trial Manager )
Study ID Numbers: PLQ-003
Study First Received: April 2, 2009
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00875277     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

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

ClinicalTrials.gov processed this record on May 07, 2009