Clinical trial NCT01360944: Exploratory Study to Investigate Efficacy of LAS41004 in a Psoriasis Plaque Test
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: PPT, topical, psoriasis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
Collaborators: name: Sciderm GmbH
First posted: 2011-05-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Decrease in thickness of infiltration
timeFrame: Day 1 (baseline) vs day 15 day (final)
Secondary outcomes:
measure: Change in clinical score
timeFrame: day 1 (baseline) vs day 15 (final)
measure: Change in erythema score
timeFrame: day1 (baseline) vs day 15 (final)
measure: Change in Induration score
timeFrame: day 1 (baseline) vs day 15 (final)
measure: Change in Scaling score
timeFrame: day 1 (baseline) vs day 15 (final)
Other outcomes:
Locations:
city: Mahlow
country: Germany
facility: Investigational site
Study officials:
affiliation: Almirall Hermal
name: Christoph Willers, MD
role: STUDY_DIRECTOR
References: