Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis

November 4, 2014 updated by: G. Pohl-Boskamp GmbH & Co. KG

A Single-centre Randomised, Active-controlled, Observer-blinded, Parallel Group Trial to Evaluate the Efficacy and Safety of a Topical Dimeticone Formulation (Loion®) Compared to 10% Salicylic Acid in the Removal of Scaling in Patients With Chronic Psoriasis Capitis

The study will be conducted to evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15% Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis (scalp psoriasis).

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 (Actual)

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.
90

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
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf (UKE)

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • Having a diagnosis of chronic psoriasis capitis (scalp psoriasis) with or without the involvement of other body areas and with or without psoriatic arthritis.
  • PSSI ≥5 (range 0-72)
  • Scaling ≥2 (on an scale from 0 to 4)
  • At least 10% of scalp area affected
  • If a women:
  • Postmenopausal
  • Premenopausal and using an established oral, injected or implanted hormonal method of contraception, intrauterine device (IUD) or intrauterine system (IUS)
  • Negative pregnancy test at inclusion
  • Patients with no concomitant systemic psoriasis medication.
  • Willingness and adherence to the prohibitions and restrictions specified in the study protocol.
  • Willingness to self-administer the drug.
  • Signed informed consent document indicating that the patient to be included understands the purpose of and the procedures for the study and is willing to participate.

Exclusion Criteria:

  • Patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, guttate, pustular).
  • Patients with uncontrolled psoriasis under the current treatment.
  • Patients having received topical keratolytic agents for the scalp within the past 2 weeks and topical steroids for the scalp within the past week (prior to inclusion).
  • Patients receiving systemic antipsoriatic drugs, immunosuppressants or systemic corticosteroids (within 4 weeks prior to inclusion).
  • Women who are pregnant or breastfeeding or planning to become pregnant during the observational period.
  • Patients participating in another study using an investigational agent or procedure during participation in the study observation period.
  • Known hypersensitivity to any ingredient in the investigational products' formulations.
  • Having any condition that in the opinion of the investigator makes the participation not be in the best interest of the subject.
  • Employees and staff of the investigator or study site with direct involvement in the study as well as family members of the employee or the investigator.

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: Parallel 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.
Experimental: Loion
Drug: Dimethicone
The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.
Active Comparator: SA-Gel
Drug: Salicylic Acid
The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.

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
Change from Baseline in Scaling
Time Frame: at Day 7
To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 7

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
Psoriasis Scalp Severity Index (PSSI)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psoriasis Area Severity Index (PASI)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14
Body Surface Area (BSA)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14
Physician Global Assessment (PGA)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate global severity of skin of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14
Scalp Physician Global Assessment (sPGA)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate global severity of scalp skin of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14
Dermatology Life Quality Index (DLQI)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate disease related quality of life of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14
Patient Benefit Index (PBI)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate the patient benefit of Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14
EuroQol Questionnaire (EQ-5D)
Time Frame: at Day 0, day 3, day 7, day 14
To evaluate general state of health of patients exposed to Loion or standard therapy for psoriasis capitis
at Day 0, day 3, day 7, day 14
Adverse and serious adverse events
Time Frame: 14 days
Risk for adverse events and serious adverse events for patients exposed to Loion or standard therapy for psoriasis capitis
14 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.
G. Pohl-Boskamp GmbH & Co. KG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthias Augustin, Prof., University Medical Center Hamburg-Eppendorf (UKE)

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.
August 1, 2013

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.
January 1, 2014

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.
January 1, 2014

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).
July 17, 2013

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.
July 30, 2013

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.
August 2, 2013

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.
November 5, 2014

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.
November 4, 2014

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.
February 1, 2014

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.
  • 0741/179

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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