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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360944
• Other study ID #: H553000-1006
• Secondary ID: 2011-000186-13
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2011
• Last updated: June 4, 2015
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Germany	Investigational site	Mahlow

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Sciderm GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in thickness of infiltration	measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)	Day 1 (baseline) vs day 15 day (final)	No
Secondary	Change in clinical score	scoring of total symptom score (0 - 12)will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day 1 (baseline) vs day 15 (final)	No
Secondary	Change in erythema score	scoring of erythema (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day1 (baseline) vs day 15 (final)	No
Secondary	Change in Induration score	scoring of induration (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day 1 (baseline) vs day 15 (final)	No
Secondary	Change in Scaling score	scoring of scaling (0-4) will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)	day 1 (baseline) vs day 15 (final)	No