A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01580488
First received: April 16, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: B LEO 35299 20 mg/g cream
Drug: C LEO 35299 20 mg/g cream
Drug: E LEO 35299 10 mg/g solution
Drug: F LEO 35299 10 mg/g solution
Drug: Daivonex® ointment
Drug: Daivonex® ointment vehicle
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Change in the Total Clinical Score From Baseline to Day 22 [ Time Frame: Baseline to Day 22 ] [ Designated as safety issue: No ]
    Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)


Secondary Outcome Measures:
  • Change in Erythema From Baseline to Day 22 [ Time Frame: Baseline to Day 22 ] [ Designated as safety issue: No ]
    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).

  • Change in Infiltration From Baseline to Day 22 [ Time Frame: Baseline to Day 22 ] [ Designated as safety issue: No ]
    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).

  • Change in Scaling From Baseline to Day 22 [ Time Frame: Baseline to Day 22 ] [ Designated as safety issue: No ]
    Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).

  • Change in Lesion Thickness From Baseline to Day 22 [ Time Frame: Baseline to Day 22 ] [ Designated as safety issue: No ]
    Change in total skin thickness measured by ultrasound from baseline to end of treatment

  • Change in Skin Thickness From Baseline to Day 22 [ Time Frame: Baseline to Day 22 ] [ Designated as safety issue: No ]
    Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment


Enrollment: 24
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: B LEO 35299 20 mg/g cream
    once daily application, 3 weeks
    Drug: C LEO 35299 20 mg/g cream
    once daily application, 3 weeks
    Drug: E LEO 35299 10 mg/g solution
    once daily application, 3 weeks
    Drug: F LEO 35299 10 mg/g solution
    once daily application, 3 weeks
    Drug: Daivonex® ointment
    once daily application, 3 weeks
    Drug: Daivonex® ointment vehicle
    once daily application, 3 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
  2. Age 18 years or above.
  3. Males, or females of non-child bearing potential.
  4. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).

Exclusion Criteria:

  1. Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
  2. Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
  3. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5 half-lives (which-ever islonger) for experimental biological products prior to randomisation and during the study.
  4. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
  5. Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:

    - Potent or very potent (WHO group III-IV) corticosteroids.

  6. Subjects using of phototherapy within the following time periods prior to randomisation and during the study:

    • PUVA (4 weeks)
    • UVB (2 weeks)
  7. Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:

    • WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
    • Topical retinoids
    • Vitamin D analogues
    • Topical immunomodulators (e.g. macrolides)
    • Anthracen derivatives
    • Tar,
    • Salicylic acid.
  8. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
  9. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
  10. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
  11. Subjects with current participation in any other interventional clinical, based on interview of the subject
  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: NCT01580488

Locations
France
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière
Nice, France, 06202
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Catherine Queille-Roussel, MD Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01580488     History of Changes
Other Study ID Numbers: PLQ-008, 2011-005349-11
Study First Received: April 16, 2012
Results First Received: August 19, 2013
Last Updated: November 8, 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
Pharmaceutical Solutions
Calcipotriene
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on October 19, 2014