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

An Investigator-blind, Controlled Exploratory Study to Assess the Efficacy and Safety of Different Concentrations of Active Ingredients in the Project LAS 41004 Compared to a Bland Ointment and to Active Control in a Psoriasis- Plaque- Test

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: LAS41004; Drug: reference

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Mahlow, Germany
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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.

Key Exclusion Criteria:

• Too small a body surface area covered with psoriasis plaques that meet the specified inclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAS 41004, variant 1, once daily; variant 1, once daily	Drug: LAS41004; once daily, topical, 100 microgram
Experimental: LAS41004, variant 2, once daily; variant 2, once daily	Drug: LAS41004; once daily, topical, 100 microgram
Experimental: LAS41004, variant 3, once daily; variant 3, once daily	Drug: LAS41004; once daily, topical, 100 microgram
Experimental: LAS41004, variant 4, once daily; variant 4, once daily	Drug: LAS41004; once daily, topical, 100 microgram
Experimental: LAS41004, variant 5, once daily; variant 5, once daily	Drug: LAS41004; once daily, topical, 100 microgram
Experimental: LAS41004, variant 6, once daily; variant 6, once daily	Drug: LAS41004; once daily, topical, 100 microgram
Placebo Comparator: reference; once daily, 100microgram	Drug: reference; once daily, 100 microgram
Active Comparator: reference, once daily; once daily	Drug: reference; once daily, 100 microgram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in thickness of infiltration	measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)	Day 1 (baseline) vs day 15 day (final)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical score	scoring of total symptom score (0 - 12)will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day 1 (baseline) vs day 15 (final)
Change in erythema score	scoring of erythema (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day1 (baseline) vs day 15 (final)
Change in Induration score	scoring of induration (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day 1 (baseline) vs day 15 (final)
Change in Scaling score	scoring of scaling (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day 1 (baseline) vs day 15 (final)

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: Sciderm GmbH

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 24, 2011
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: PPT, topical, psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: H553000-1006; 2011-000186-13 (EudraCT Number)