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Completed

NCT Number: NCT01360944

Exploratory Study to Investigate Efficacy of LAS41004 in a Psoriasis Plaque Test

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site

Mahlow, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAS41004

Drug

once daily, topical, 100 microgram

reference

Drug

once daily, 100 microgram

Primary outcomes

  1. Decrease in thickness of infiltration

    Time frame: Day 1 (baseline) vs day 15 day (final)

    measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)

Secondary outcomes

  1. Change in clinical score

    Time frame: day 1 (baseline) vs day 15 (final)

    scoring of total symptom score (0 - 12)will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)

  2. Change in erythema score

    Time frame: day1 (baseline) vs day 15 (final)

    scoring of erythema (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)

  3. Change in Induration score

    Time frame: day 1 (baseline) vs day 15 (final)

    scoring of induration (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)

  4. Change in Scaling score

    Time frame: day 1 (baseline) vs day 15 (final)

    scoring of scaling (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Collaborators

  • Sciderm GmbH

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 26, 2011
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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