Study to Investigate Dose-related Efficacy of LAS41004 in the Treatment of Psoriasis

May 28, 2015 updated by: Almirall, S.A.

An Investigator-blind, Controlled Study to Assess the Efficacy of Six Distinct Combinations of LAS 41004 in Different Concentrations Compared to Placebo and to Active Control in a Psoriasis-Plaque-Test

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mahlow, Germany, 15831
        • Almirall Investigational Sites#1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 6 month

  • Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria:

    1. 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
    2. Comparable psoriasis plaques with at least "2" in each score (Range 0-4) for the three distinct symptoms scaling; erythema; and induration
    3. 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
    4. Enough psoriatic surface area to define 8 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 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:

    1. Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
    2. Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
    3. Intrauterine device (IUD) inserted for at least 1 month prior to study entrance

Exclusion Criteria:

  • Too few body surface area covered with psoriasis plaques that meet the specified inclusion criteria to be defined as 8 clearly distinguishable test areas
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo, once daily
Experimental: LAS 41004 dosage 1
Drug: LAS 41004
LAS 41004 dosage 1, once daily
Drug: LAS 41004
LAS 41004 dosage 2, once daily
Drug: LAS 41004
LAS 41004 dosage 3, once daily
Drug: LAS 41004
LAS 41004 dosage 4, once daily
Drug: LAS 41004
LAS 41004 , dosage 5, once daily
Experimental: LAS 41004 dosage 2
Drug: LAS 41004
LAS 41004 dosage 1, once daily
Drug: LAS 41004
LAS 41004 dosage 2, once daily
Drug: LAS 41004
LAS 41004 dosage 3, once daily
Drug: LAS 41004
LAS 41004 dosage 4, once daily
Drug: LAS 41004
LAS 41004 , dosage 5, once daily
Experimental: LAS 41004 dosage 3
Drug: LAS 41004
LAS 41004 dosage 1, once daily
Drug: LAS 41004
LAS 41004 dosage 2, once daily
Drug: LAS 41004
LAS 41004 dosage 3, once daily
Drug: LAS 41004
LAS 41004 dosage 4, once daily
Drug: LAS 41004
LAS 41004 , dosage 5, once daily
Experimental: LAS 41004 dosage 4
Drug: LAS 41004
LAS 41004 dosage 1, once daily
Drug: LAS 41004
LAS 41004 dosage 2, once daily
Drug: LAS 41004
LAS 41004 dosage 3, once daily
Drug: LAS 41004
LAS 41004 dosage 4, once daily
Drug: LAS 41004
LAS 41004 , dosage 5, once daily
Experimental: LAS 41004 dosage 5
Drug: LAS 41004
LAS 41004 dosage 1, once daily
Drug: LAS 41004
LAS 41004 dosage 2, once daily
Drug: LAS 41004
LAS 41004 dosage 3, once daily
Drug: LAS 41004
LAS 41004 dosage 4, once daily
Drug: LAS 41004
LAS 41004 , dosage 5, once daily
Experimental: LAS 41004 dosage 6
Drug: LAS 41004 dosage 6
LAS 41004, dosage 6, once daily
Active Comparator: Reference
Drug: Reference
Reference, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decrease in skin thickness
Time Frame: 15 days
measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in clinical score
Time Frame: 15 days
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
15 days
change in erythema score
Time Frame: 15 days
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
15 days
change in induration score
Time Frame: 15 days
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
15 days
change in scaling score
Time Frame: 15 days
scoring will be performed by investigator, comparing data from baseline (day1) vs end of trial (day15)
15 days
Number of skin reactions per patient as a measure of safety and tolerability
Time Frame: 15 days
scoring will be performed by investigator
15 days
Number of Adverse Events per patients as a measure of safety and tolerability
Time Frame: 15 days
reporting will be performed by investigator
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Almirall, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H553000-1001
  • 2010-018355-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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