A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580488
• Other study ID #: PLQ-008
• Secondary ID: 2011-005349-11
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2012
• Last updated: November 8, 2013
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• B LEO 35299 20 mg/g cream
once daily application, 3 weeks
• C LEO 35299 20 mg/g cream
once daily application, 3 weeks
• E LEO 35299 10 mg/g solution
once daily application, 3 weeks
• F LEO 35299 10 mg/g solution
once daily application, 3 weeks
• Daivonex® ointment
once daily application, 3 weeks
• Daivonex® ointment vehicle
once daily application, 3 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No