Real-life Evaluation of the Daivobet® Gel Applicator

Completed

• Conditions: Plaque Psoriasis

• Registration Number: NCT02856542
• Lead Sponsor: LEO Pharma

Brief Summary

This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-23
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1560

Inclusion Criteria

• Age ≥ 18 years
• Dermatologist or general practitioner has decided to initiate treatment with Daivobet® gel Applicator

Exclusion Criteria

• Indication not within the approved labelling in France
• Contraindication for treatment with calcipotriol or betamethasone dipropionate
• Informed consent to participate in the study has not been obtained

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morisky Medication Adherence Scale-8	4 weeks	Degree of adherence to prescribed treatment

Secondary Outcome Measures

Name	Time	Method
Patient opinion on Applicator usability	4 weeks	5-point Likert scale
Patient overall satisfaction	4 weeks	4 point Likert scale
Patient Global Impression of Improvement	4 weeks	7 point Likert scale
Investigator's opinion on the properties of the Applicator	Baseline	5 point rating scale

Trial Locations

Locations (1)

Cabinet de Dermatologie, Dr. Mathilde Kemula; 🇫🇷 Charenton le Pont, France