Real-life Evaluation of the Daivobet® Gel Applicator

Plaque Psoriasis Clinical Trial

— ASAP PSO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856542
• Other study ID #: NIS-DAIVOBETGEL-1284
• Status: Completed
• Phase: N/A
• First received: July 11, 2016
• Last updated: October 18, 2017
• Start date: May 23, 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1560
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• calcipotriol/betamethasone dipropionate gel in Applicator
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.

Locations

Country	Name	City	State
France	Cabinet de Dermatologie, Dr. Mathilde Kemula	Charenton le Pont

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

References & Publications (1)

Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morisky Medication Adherence Scale-8	Degree of adherence to prescribed treatment	2 weeks
Primary	Morisky Medication Adherence Scale-8	Degree of adherence to prescribed treatment	4 weeks
Secondary	Patient opinion on Applicator usability	5-point Likert scale	4 weeks
Secondary	Patient overall satisfaction	4 point Likert scale	4 weeks
Secondary	Patient Global Impression of Improvement	7 point Likert scale	2 weeks
Secondary	Patient Global Impression of Improvement	7 point Likert scale	4 weeks
Secondary	Investigator's opinion on the properties of the Applicator	5 point rating scale	Baseline