Clinical trial NCT01119339: Study to Investigate Dose-related Efficacy of LAS41004 in the Treatment of Psoriasis
Official title: An Investigator-blind, Controlled Study to Assess the Efficacy of Six Distinct Combinations of LAS 41004 in Different Concentrations Compared to Placebo and to Active Control in a Psoriasis-Plaque-Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
topical
psoriasis plaques test
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


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

  1. 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
  2. Comparable psoriasis plaques with at least "2" in each score (Range 0-4) for the three distinct symptoms scaling; erythema; and induration
  3. 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
  4. Enough psoriatic surface area to define 8 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 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:

  1. Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
  2. Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
  3. 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 8 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

Primary outcomes:
measure: Decrease in skin thickness
timeFrame: 15 days
Secondary outcomes:
measure: change in clinical score
timeFrame: 15 days
measure: change in erythema score
timeFrame: 15 days
measure: change in induration score
timeFrame: 15 days
measure: change in scaling score
timeFrame: 15 days
measure: Number of skin reactions per patient as a measure of safety and tolerability
timeFrame: 15 days
measure: Number of Adverse Events per patients as a measure of safety and tolerability
timeFrame: 15 days
Other outcomes:
Locations:
city: Mahlow
country: Germany
facility: Almirall Investigational Sites#1
Study officials:
affiliation: Almirall Hermal GmbH
name: Christoph Willers, MD, MBA
role: STUDY_DIRECTOR
References: