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

This study has been completed.
Sponsor:
Collaborator:
Sciderm GmbH
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01360944
First received: May 24, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Psoriasis Vulgaris
Drug: LAS41004
Drug: reference
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Decrease in thickness of infiltration [ Time Frame: Day 1 (baseline) vs day 15 day (final) ] [ Designated as safety issue: No ]
    measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)


Secondary Outcome Measures:
  • Change in clinical score [ Time Frame: day 1 (baseline) vs day 15 (final) ] [ Designated as safety issue: No ]
    scoring of total symptom score (0 - 12)will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)

  • Change in erythema score [ Time Frame: day1 (baseline) vs day 15 (final) ] [ Designated as safety issue: No ]
    scoring of erythema (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)

  • Change in Induration score [ Time Frame: day 1 (baseline) vs day 15 (final) ] [ Designated as safety issue: No ]
    scoring of induration (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)

  • Change in Scaling score [ Time Frame: day 1 (baseline) vs day 15 (final) ] [ Designated as safety issue: No ]
    scoring of scaling (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)


Enrollment: 22
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAS 41004, variant 1, once daily
variant 1, once daily
Drug: LAS41004
once daily, topical, 100 microgram
Experimental: LAS41004, variant 2, once daily
variant 2, once daily
Drug: LAS41004
once daily, topical, 100 microgram
Experimental: LAS41004, variant 3, once daily
variant 3, once daily
Drug: LAS41004
once daily, topical, 100 microgram
Experimental: LAS41004, variant 4, once daily
variant 4, once daily
Drug: LAS41004
once daily, topical, 100 microgram
Experimental: LAS41004, variant 5, once daily
variant 5, once daily
Drug: LAS41004
once daily, topical, 100 microgram
Experimental: LAS41004, variant 6, once daily
variant 6, once daily
Drug: LAS41004
once daily, topical, 100 microgram
Placebo Comparator: reference
once daily, 100microgram
Drug: reference
once daily, 100 microgram
Active Comparator: reference, once daily
once daily
Drug: reference
once daily, 100 microgram

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360944

Locations
Germany
Investigational site
Mahlow, Germany
Sponsors and Collaborators
Almirall, S.A.
Sciderm GmbH
Investigators
Study Director: Christoph Willers, MD Almirall Hermal
  More Information

No publications provided

Responsible Party: Dr G Ocker, Almirall Hermal GmbH, GCD
ClinicalTrials.gov Identifier: NCT01360944     History of Changes
Other Study ID Numbers: H553000-1006, 2011-000186-13
Study First Received: May 24, 2011
Last Updated: July 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:
PPT, topical, psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014