Clinical Trial to Investigate Efficacy of LAS41004 in Psoriasis

An Investigator-blind, Controlled Study to Assess the Efficacy of Distinct Combinations of LAS 41004 in Different Concentrations Compared to Placebo and to Active Control in a Psoriasis-Plaque-Test

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Experimental: LAS 41004 dosage 1; Drug: Experimental: LAS 41004 dosage 2; Drug: Experimental: LAS 41004 dosage 3; Drug: Placebo Comparator: placebo; Drug: Reference

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Mahlow, Germany
    • Almirall Investigational Sites#1

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

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 6 month

  • Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria:

    • Psoriasis plaques must be located at 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 psoriasis plaques with at least "2" in each score (Range 0-4) for the three distinct symptoms 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 psoriasis plaques
    • Enough psoriatic surface area to define 5 clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² plaque size
  • Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere SCIderm GmbH Confidential Almirall Hermal GmbH Study protocol EudraCT No. 2010-022281-27 Protocol No. H553000-1005 Version 1.0 to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
  • Written informed consent to participate in the study, prior to any study related procedures, indicating an understanding of the purpose of the study

  • A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study and the following 4 weeks after the end of study :

    • Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
    • Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
    • Intrauterine device (IUD) inserted for at least 1 month prior to study entrance

Exclusion Criteria:

• Too few body surface area covered with psoriasis plaques that meet the specified inclusion criteria to be defined as 5 clearly distinguishable test areas
• Any condition that may interfere with the study assessments or sonographic measurements of the skin and/or may have an influence on skin immune response (incl. open wounds)
• Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products
• No willingness to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course
• No willingness to avoid swimming, bathing or wetting of the designated test areas between visits
• Pregnant or breast-feeding women
• A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial (including but not limited to: serious infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, uncontrolled metabolic diseases, disorders of the calcium metabolism, autoimmune diseases)
• History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases
• Current diagnosis of guttate, erythrodermic or pustular psoriasis
• Patients who did not respect the following wash-out periods prior or during the study:

Treatment Wash out period Topical treatment in the test area Any topical anti-psoriatic drug 2 weeks Systemic treatment Biologics 6 months Any other systemic treatment (corticosteroids, ciclosporin, MTX, fumaric acid esters) 3 months Procedures Phototherapy 4 weeks

• Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), incl. 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
• Vaccination 6 days prior to enrolment or during the study
• Subjects who are - in the opinion of the investigator - unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with psoriasis or the conduct of the trial
• Participation in any other clinical trial within 30 days prior or during this trial
• Subject is an adult under guardianship, hospitalised, deprived of freedom or unable to communicate or cooperate with the investigator due to language or mental problems

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAS 41004 dosage 1; dosage 1, once daily	Drug: Experimental: LAS 41004 dosage 1; dosage 1, once daily
Experimental: LAS 41004 dosage 2; dosage 2, once daily	Drug: Experimental: LAS 41004 dosage 2; LAS 41004 dosage 2, once daily
Experimental: LAS 41004 dosage 3; dosage 3, once daily	Drug: Experimental: LAS 41004 dosage 3; dosage 3, once daily
Placebo Comparator: placebo; once daily	Drug: Placebo Comparator: placebo; once daily
Active Comparator: Reference; once daily	Drug: Reference; Active Comparator,once daily

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)	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical score	scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	15 days
Change in erythema score	scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	15 days
Change in Induration score	scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	15 days
Change in Scaling score	scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	15 days
Number of skin reactions per patient as a measure of safety and tolerability	daily scoring will be performed by investigator	15 days
Number of AEs per patients as a measure of safety and tolerability	reporting will be performed by investigator	15 days

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: topical; psoriasis; PPT
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: H553000-1005; 2010-022281-27 (EudraCT Number)