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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Nice, France, 06202
    • Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Total Clinical Score From Baseline to Day 22	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)	Baseline to Day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Erythema From Baseline to Day 22	Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).	Baseline to Day 22
Change in Infiltration From Baseline to Day 22	Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).	Baseline to Day 22
Change in Scaling From Baseline to Day 22	Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).	Baseline to Day 22
Change in Lesion Thickness From Baseline to Day 22	Change in total skin thickness measured by ultrasound from baseline to end of treatment	Baseline to Day 22
Change in Skin Thickness From Baseline to Day 22	Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment	Baseline to Day 22

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 30, 2013
• Last Update Submitted That Met QC Criteria: November 8, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcipotriene; Pharmaceutical Solutions; Calcitriol
• Other Study ID Numbers: PLQ-008; 2011-005349-11 (EudraCT Number)