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

Primary Purpose

Scalp Psoriasis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Dimethicone
Salicylic Acid
Sponsored by
G. Pohl-Boskamp GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scalp Psoriasis focused on measuring Psoriasis capitis, Scaling, Salicylic acid, Dimethicone, Plaque removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Center Hamburg-Eppendorf (UKE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Loion

SA-Gel

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Scaling
To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis

Secondary Outcome Measures

Psoriasis Scalp Severity Index (PSSI)
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis

Full Information

First Posted
July 17, 2013
Last Updated
November 4, 2014
Sponsor
G. Pohl-Boskamp GmbH & Co. KG
Collaborators
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01914627
Brief Title
Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G. Pohl-Boskamp GmbH & Co. KG
Collaborators
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis
Keywords
Psoriasis capitis, Scaling, Salicylic acid, Dimethicone, Plaque removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loion
Arm Type
Experimental
Arm Title
SA-Gel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dimethicone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Salicylic Acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Scaling
Description
To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 7
Secondary Outcome Measure Information:
Title
Psoriasis Scalp Severity Index (PSSI)
Description
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Other Pre-specified Outcome Measures:
Title
Psoriasis Area Severity Index (PASI)
Description
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Title
Body Surface Area (BSA)
Description
To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Title
Physician Global Assessment (PGA)
Description
To evaluate global severity of skin of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Title
Scalp Physician Global Assessment (sPGA)
Description
To evaluate global severity of scalp skin of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Title
Dermatology Life Quality Index (DLQI)
Description
To evaluate disease related quality of life of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Title
Patient Benefit Index (PBI)
Description
To evaluate the patient benefit of Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Title
EuroQol Questionnaire (EQ-5D)
Description
To evaluate general state of health of patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
at Day 0, day 3, day 7, day 14
Title
Adverse and serious adverse events
Description
Risk for adverse events and serious adverse events for patients exposed to Loion or standard therapy for psoriasis capitis
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Augustin, Prof.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf (UKE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf (UKE)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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