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Completed

NCT Number: NCT02856542

Real-life Evaluation of the Daivobet® Gel Applicator

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet de Dermatologie, Dr. Mathilde Kemula

Charenton-le-Pont, 94220, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

calcipotriol/betamethasone dipropionate gel in Applicator

Drug

Topical treatment of scalp using applicator device. The study as such is non-interventional as the intervention has been decided prior to and independently from the inclusion of the patient in the cohort to be observed.

Other names: Daivobet® gel Applicator

Primary outcomes

  1. Morisky Medication Adherence Scale-8

    Time frame: 2 weeks

    Degree of adherence to prescribed treatment

  2. Morisky Medication Adherence Scale-8

    Time frame: 4 weeks

    Degree of adherence to prescribed treatment

Secondary outcomes

  1. Patient opinion on Applicator usability

    Time frame: 4 weeks

    5-point Likert scale

  2. Patient overall satisfaction

    Time frame: 4 weeks

    4 point Likert scale

  3. Patient Global Impression of Improvement

    Time frame: 2 weeks

    7 point Likert scale

  4. Patient Global Impression of Improvement

    Time frame: 4 weeks

    7 point Likert scale

  5. Investigator's opinion on the properties of the Applicator

    Time frame: Baseline

    5 point rating scale

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

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

Acronym: ASAP PSO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 5, 2016
Registry last updated
Oct 19, 2017

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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