Clinical Trial to Investigate Efficacy of LAS41004 in Psoriasis

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference	Reference	once daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Number of AEs per patients as a measure of safety and tolerability	15 days	reporting will be performed by investigator
Number of skin reactions per patient as a measure of safety and tolerability	15 days	daily scoring will be performed by investigator
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)

Clinical Trial to Investigate Efficacy of LAS41004 in Psoriasis

Recruitment & Eligibility

Study & Design

Trial Locations

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