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Trial record 2 of 6 for:    LAS41004

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

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ClinicalTrials.gov Identifier: NCT01360944
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Sciderm GmbH
Information provided by (Responsible Party):
Almirall, S.A.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: LAS41004 Drug: reference Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360944


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

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01360944     History of Changes
Other Study ID Numbers: H553000-1006
2011-000186-13 ( EudraCT Number )
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

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

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