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

April 16, 2012
November 8, 2013
April 2012
June 2012   (final data collection date for primary outcome measure)
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)
Change from baseline to end of treatment in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) [ Time Frame: 3 weeks (end of treatment, Day 22) ] [ Designated as safety issue: No ]
TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)
Complete list of historical versions of study NCT01580488 on ClinicalTrials.gov Archive Site
  • 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
  • Change from baseline in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits [ Time Frame: 3 weeks (Day 1, 4, 8, 11, 15, 18, 22) ] [ Designated as safety issue: No ]
  • Change from baseline to end of treatment in lesion thickness (total and echo-poor band) measured by ultrasound. [ Time Frame: 3 weeks (Day 1, 22) ] [ Designated as safety issue: No ]
  • Change from baseline in Total Clinical Score (TCS) at individual visits. [ Time Frame: 3 weeks (Day 1, 4, 8, 11, 15, 18, 22) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris
A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Psoriasis Vulgaris
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01580488
PLQ-008, 2011-005349-11
No
LEO Pharma
LEO Pharma
Not Provided
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
LEO Pharma
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP