A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Drug: E LEO 35299 10 mg/g solution; Drug: B LEO 35299 20 mg/g cream; Drug: Daivonex® ointment; Drug: Daivonex® ointment vehicle; Drug: C LEO 35299 20 mg/g cream; Drug: F LEO 35299 10 mg/g solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01580488

2011-005349-11 (EudraCT Number)

PLQ-008

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind