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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2011

Last Updated Date

July 11, 2011

Start Date ^ICMJE

May 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01360944 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Psoriasis Vulgaris

Intervention ^ICMJE

Drug: LAS41004
once daily, topical, 100 microgram
Drug: reference
once daily, 100 microgram

Study Arm (s)

Experimental: LAS 41004, variant 1, once daily
variant 1, once daily

Intervention: Drug: LAS41004
Experimental: LAS41004, variant 2, once daily
variant 2, once daily

Intervention: Drug: LAS41004
Experimental: LAS41004, variant 3, once daily
variant 3, once daily

Intervention: Drug: LAS41004
Experimental: LAS41004, variant 4, once daily
variant 4, once daily

Intervention: Drug: LAS41004
Experimental: LAS41004, variant 5, once daily
variant 5, once daily

Intervention: Drug: LAS41004
Experimental: LAS41004, variant 6, once daily
variant 6, once daily

Intervention: Drug: LAS41004
Placebo Comparator: reference
once daily, 100microgram

Intervention: Drug: reference
Active Comparator: reference, once daily
once daily

Intervention: Drug: reference

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01360944

Other Study ID Numbers ^ICMJE

H553000-1006, 2011-000186-13

Has Data Monitoring Committee

Responsible Party

Dr G Ocker, Almirall Hermal GmbH, GCD

Study Sponsor ^ICMJE

Almirall, S.A.

Collaborators ^ICMJE

Sciderm GmbH

Investigators ^ICMJE

Study Director:

Christoph Willers, MD

Almirall Hermal

Information Provided By

Almirall, S.A.

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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