A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

NCT ID: NCT01580488

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Interventions

B LEO 35299 20 mg/g cream

once daily application, 3 weeks

Intervention Type: DRUG

C LEO 35299 20 mg/g cream

once daily application, 3 weeks

Intervention Type: DRUG

E LEO 35299 10 mg/g solution

once daily application, 3 weeks

Intervention Type: DRUG

F LEO 35299 10 mg/g solution

once daily application, 3 weeks

Intervention Type: DRUG

Daivonex® ointment

once daily application, 3 weeks

Intervention Type: DRUG

Daivonex® ointment vehicle

once daily application, 3 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Queille-Roussel, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France

Locations

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

Nice, , France

Countries

France

Other Identifiers

2011-005349-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PLQ-008

Identifier Type: -

Identifier Source: org_study_id