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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014