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

• Sponsor: Almirall, S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01360944
• Collaborator: Sciderm GmbH (Industry)
• Enrollment: 22
• Location: 1
• Arms: 8
• Duration (Months): 1
• Patients Per Site Per Month: 21.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Decrease in thickness of infiltration [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 [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 [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 [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 [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Investigational site	Mahlow		Germany

Sponsors and Collaborators

• Almirall, S.A.
• Sciderm GmbH

Investigators

• Study Director: Christoph Willers, MD, Almirall Hermal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Almirall, S.A.
• ClinicalTrials.gov Identifier: NCT01360944
• Other Study ID Numbers: H553000-1006; 2011-000186-13
• First Posted: May 26, 2011
• Last Update Posted: Jun 8, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Almirall, S.A.: PPT, topical, psoriasis
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Jun 8, 2015