Real-life Evaluation of the Daivobet® Gel Applicator (ASAP PSO)

October 18, 2017 updated by: LEO Pharma

Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Charenton le Pont, France, 94220
        • Cabinet de Dermatologie, Dr. Mathilde Kemula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with psoriasis vulgaris affecting the scalp who are prescribed scalp treatment with Daivobet® gel Applicator.

Representativeness is ensured through random sampling of investigators to be invited to participate from a country wide list of dermatologists and general practitioners, with adjustment for regional distribution. Investigators include their first three patients meeting the study criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morisky Medication Adherence Scale-8
Time Frame: 2 weeks
Degree of adherence to prescribed treatment
2 weeks
Morisky Medication Adherence Scale-8
Time Frame: 4 weeks
Degree of adherence to prescribed treatment
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient opinion on Applicator usability
Time Frame: 4 weeks
5-point Likert scale
4 weeks
Patient overall satisfaction
Time Frame: 4 weeks
4 point Likert scale
4 weeks
Patient Global Impression of Improvement
Time Frame: 2 weeks
7 point Likert scale
2 weeks
Patient Global Impression of Improvement
Time Frame: 4 weeks
7 point Likert scale
4 weeks
Investigator's opinion on the properties of the Applicator
Time Frame: Baseline
5 point rating scale
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Mathilde Kemula, MD, Cabinet de Dermatologie, Dr. Mathilde Kemula
  • Principal Investigator: Frederic Bonnier, MD, General Practice, 356 Rue de Charles de Gaulle, 91400 Orsay
  • Principal Investigator: Nathalie Quiles, MD, Hôpital Saint Joseph, 26 Boulevard de Louvain, Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-DAIVOBETGEL-1284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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