Clinical Trial to Investigate Efficacy of LAS41004 in Psoriasis

NCT01283698 | Completed Phase 2

• 2 other identifiers: H553000-10052010-022281-27
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Keywords

psoriasis; topical; PPT

Outcome Measures

Primary Outcomes (1)

• Decrease in thickness of infiltration

  measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)

  15 days

Secondary Outcomes (6)

• Change in clinical score

  15 days

• Change in erythema score

  15 days

• Change in Induration score

  15 days

• Change in Scaling score

  15 days

• Number of skin reactions per patient as a measure of safety and tolerability

  15 days

Study Arms (5)

LAS 41004 dosage 1

EXPERIMENTAL

dosage 1, once daily

Drug: Experimental: LAS 41004 dosage 1

LAS 41004 dosage 2

EXPERIMENTAL

dosage 2, once daily

Drug: Experimental: LAS 41004 dosage 2

LAS 41004 dosage 3

EXPERIMENTAL

dosage 3, once daily

Drug: Experimental: LAS 41004 dosage 3

placebo

PLACEBO COMPARATOR

once daily

Drug: Placebo Comparator: placebo

Reference

ACTIVE COMPARATOR

once daily

Drug: Reference

Interventions

Experimental: LAS 41004 dosage 1 DRUG

dosage 1, once daily

LAS 41004 dosage 1

Experimental: LAS 41004 dosage 2 DRUG

LAS 41004 dosage 2, once daily

LAS 41004 dosage 2

Experimental: LAS 41004 dosage 3 DRUG

dosage 3, once daily

LAS 41004 dosage 3

Placebo Comparator: placebo DRUG

once daily

placebo

Reference DRUG

Active Comparator,once daily

Reference

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 6 month
• Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria:
• Psoriasis plaques must be located at 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 psoriasis plaques with at least "2" in each score (Range 0-4) for the three distinct symptoms 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 psoriasis plaques
• Enough psoriatic surface area to define 5 clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² plaque size
• Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere SCIderm GmbH Confidential Almirall Hermal GmbH Study protocol EudraCT No. 2010-022281-27 Protocol No. H553000-1005 Version 1.0 to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
• Written informed consent to participate in the study, prior to any study related procedures, indicating an understanding of the purpose of the study
• A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study and the following 4 weeks after the end of study :
• Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
• Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
• Intrauterine device (IUD) inserted for at least 1 month prior to study entrance

You may not qualify if:

• Any condition that may interfere with the study assessments or sonographic measurements of the skin and/or may have an influence on skin immune response (incl. open wounds)
• Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products
• No willingness to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course
• No willingness to avoid swimming, bathing or wetting of the designated test areas between visits
• Pregnant or breast-feeding women
• A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial (including but not limited to: serious infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, uncontrolled metabolic diseases, disorders of the calcium metabolism, autoimmune diseases)
• History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases
• Current diagnosis of guttate, erythrodermic or pustular psoriasis
• Patients who did not respect the following wash-out periods prior or during the study:
• Treatment Wash out period Topical treatment in the test area Any topical anti-psoriatic drug 2 weeks Systemic treatment Biologics 6 months Any other systemic treatment (corticosteroids, ciclosporin, MTX, fumaric acid esters) 3 months Procedures Phototherapy 4 weeks
• Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), incl. 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
• Vaccination 6 days prior to enrolment or during the study
• Subjects who are - in the opinion of the investigator - unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with psoriasis or the conduct of the trial

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Almirall Investigational Sites#1

Mahlow, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christoph Willers, MD, MBA

  Almirall Hermal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

DE (1)