Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

Phase 3

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: LEO 90100 Aerosol Foam; Drug: Daivobet® gel

• Registration Number: NCT02310646
• Lead Sponsor: LEO Pharma

Brief Summary

To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Detailed Description

An international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Study Timeline

• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-08-01
• Results First Submitted QC: 2016-10-31
• Results First Posted: 2016-12-28
• Status Verified: 2017-05
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment group 1	LEO 90100 Aerosol Foam	Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
Treatment group 1	Daivobet® gel	Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
Treatment group 2	Daivobet® gel	Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
Treatment group 2	LEO 90100 Aerosol Foam	Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam

Primary Outcome Measures

Name	Time	Method
Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics	2 weeks	The SPA questionnaire was completed at Week 2 and consisted of 2 parts: (i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from 'very important factor' to 'not at all important factor'.; The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.; Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website.

Trial Locations

Locations (1)

K.Papp Clinical Research Inc.; 🇨🇦 Waterloo, Ontario, Canada