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Completed

NCT Number: NCT01914627

Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid 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).

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Key information

Conditions

Scalp Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dimethicone

Drug

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

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

G. Pohl-Boskamp GmbH & Co. KG

Industry

Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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