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

NCT01914627 | Completed Phase 2 DMC

• 1 other identifier: 0741/179
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Scalp Psoriasis

Keywords

Psoriasis capitis; Scaling; Salicylic acid; Dimethicone; Plaque removal

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Scaling

  To evaluate improvement of scaling of patients exposed to Loion or standard therapy for psoriasis capitis

  at Day 7

Secondary Outcomes (1)

• Psoriasis Scalp Severity Index (PSSI)

  at Day 0, day 3, day 7, day 14

Other Outcomes (8)

• Psoriasis Area Severity Index (PASI)

  at Day 0, day 3, day 7, day 14

• Body Surface Area (BSA)

  at Day 0, day 3, day 7, day 14

• Physician Global Assessment (PGA)

  at Day 0, day 3, day 7, day 14

Study Arms (2)

Loion

EXPERIMENTAL

Drug: Dimethicone

SA-Gel

ACTIVE COMPARATOR

Drug: Salicylic Acid

Interventions

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.

Loion

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.

SA-Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• Patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, guttate, pustular).
• Patients with uncontrolled psoriasis under the current treatment.
• 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.

Sponsors & Collaborators

• G. Pohl-Boskamp GmbH & Co. KG: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

Location

MeSH Terms

Interventions

dimethicone; Salicylic Acid

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Matthias Augustin, Prof.

  University Medical Center Hamburg-Eppendorf (UKE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: August 2, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 5, 2014

Record last verified: 2014-02

Locations

DE (1)