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

Scalp Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914627
• Other study ID #: 0741/179
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2013
• Last updated: November 4, 2014
• Start date: August 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: G. Pohl-Boskamp GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf (UKE)	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
G. Pohl-Boskamp GmbH & Co. KG	Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psoriasis Area Severity Index (PASI)	To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14	No
Other	Body Surface Area (BSA)	To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14	No
Other	Physician Global Assessment (PGA)	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	No
Other	Scalp Physician Global Assessment (sPGA)	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	No
Other	Dermatology Life Quality Index (DLQI)	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	No
Other	Patient Benefit Index (PBI)	To evaluate the patient benefit of Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14	No
Other	EuroQol Questionnaire (EQ-5D)	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	No
Other	Adverse and serious adverse events	Risk for adverse events and serious adverse events for patients exposed to Loion or standard therapy for psoriasis capitis	14 days	Yes
Primary	Change from Baseline in Scaling	To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 7	No
Secondary	Psoriasis Scalp Severity Index (PSSI)	To evaluate clinical outcome of patients exposed to Loion or standard therapy for psoriasis capitis	at Day 0, day 3, day 7, day 14	No