Exploratory Study to Investigate Efficacy of LAS41004 in a Psoriasis Plaque Test

NCT ID: NCT01360944

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-06-30

Brief Summary

The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT).

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LAS 41004, variant 1, once daily

variant 1, once daily

Group Type: EXPERIMENTAL

LAS41004

Intervention Type: DRUG

once daily, topical, 100 microgram

LAS41004, variant 2, once daily

variant 2, once daily

Group Type: EXPERIMENTAL

LAS41004

Intervention Type: DRUG

once daily, topical, 100 microgram

LAS41004, variant 3, once daily

variant 3, once daily

Group Type: EXPERIMENTAL

LAS41004

Intervention Type: DRUG

once daily, topical, 100 microgram

LAS41004, variant 4, once daily

variant 4, once daily

Group Type: EXPERIMENTAL

LAS41004

Intervention Type: DRUG

once daily, topical, 100 microgram

LAS41004, variant 5, once daily

variant 5, once daily

Group Type: EXPERIMENTAL

LAS41004

Intervention Type: DRUG

once daily, topical, 100 microgram

LAS41004, variant 6, once daily

variant 6, once daily

Group Type: EXPERIMENTAL

LAS41004

Intervention Type: DRUG

once daily, topical, 100 microgram

reference

once daily, 100microgram

Group Type: PLACEBO_COMPARATOR

reference

Intervention Type: DRUG

once daily, 100 microgram

reference, once daily

once daily

Group Type: ACTIVE_COMPARATOR

reference

Intervention Type: DRUG

once daily, 100 microgram

Interventions

LAS41004

once daily, topical, 100 microgram

Intervention Type: DRUG

reference

once daily, 100 microgram

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 12 months
• Psoriatic plaques that are suitable to be defined as target area lesions by the following criteria:

oPsoriatic plaques must be located on the trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas

• Comparable psoriatic plaques with at least "2" in each score (range 0-4) for the three distinct signs: scaling, erythema and induration
• No more than 3 points difference in total score (= sum of scores for scaling, erythema and induration; Range 0-12) of the chosen comparable psoriatic plaques
• Enough surface area to the psoriatic plaque to define eight clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² size - Effective contraceptive methods for the duration of the study and for the 4 weeks after study drug discontinuation, for a patient of childbearing potential.

• Any condition that may interfere with the study assessments or ultrasound measurements of the skin and/or may have an influence on the skin immune response (incl. open wounds)
• Current diagnosis of guttate, erythrodermic or pustular psoriasis
• Patients who have received any topical anti-psoriatic drug in the test area within the last 2 weeks before treatment with the IMP.
• Patients who have received topical products in the test area containing DEET (N,N-diethyl-m-polyamide), a common component of insect repellent products within 1 week before treatment with the IMP.
• Patients who have received systemic biologics within the last 6 months before treatment with the IMP or any systemic antipsoriatic treatment (corticosteroids, ciclosporin, methotrexate, fumaric acid esters, acitretin etc)within the last 3 months before treatment with the IMP.
• Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), including but not limited to: skin disease due to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, skin atrophy, striae distensae, increased fragility of skin blood vessels, ichthyosis, ulcers, wounds and reaction after vaccination
• Significant skin infections (including but not limited to: herpes, varicella, mycotic skin infections, bacterial skin infections or parasitic skin infections)
• Excessive sunlight exposure within 28 days prior to study entry and during the conduct of the study
• Usage of any topical formulation (incl. cosmetics, emollients, etc) on the designated target areas during the course of the study
• Vitamin A intake > 15,000 IU/day

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sciderm GmbH

INDUSTRY

Sponsor Role: collaborator

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Willers, MD

Role: STUDY_DIRECTOR

Almirall Hermal

Locations

Investigational site

Mahlow, , Germany

Countries

Germany

Other Identifiers

2011-000186-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H553000-1006

Identifier Type: -

Identifier Source: org_study_id