Clinical Trial to Investigate Efficacy of LAS41004 in Psoriasis

Sponsor

Almirall, S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01283698

Collaborator

(none)

Enrollment

Location

Arms

1.9

Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Experimental: LAS 41004 dosage 1 Drug: Experimental: LAS 41004 dosage 2 Drug: Experimental: LAS 41004 dosage 3 Drug: Placebo Comparator: placebo Drug: Reference	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Decrease in thickness of infiltration [15 days]
measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Almirall Investigational Sites#1	Mahlow		Germany

Sponsors and Collaborators

Almirall, S.A.

Investigators

Study Director: Christoph Willers, MD, MBA, Almirall Hermal GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Almirall, S.A.

ClinicalTrials.gov Identifier:

NCT01283698

Other Study ID Numbers:

H553000-1005
2010-022281-27

First Posted:

Jan 26, 2011

Last Update Posted:

May 29, 2015

Last Verified:

May 1, 2015

Keywords provided by Almirall, S.A.

psoriasis

topical

PPT

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of May 29, 2015