Real-life Evaluation of the Daivobet® Gel Applicator

NCT02856542 | Completed

• 1 other identifier: NIS-DAIVOBETGEL-1284
• Study Type: observational
• Target: 1,560
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis vulgaris, scalp, topical, applicator, device

Outcome Measures

Primary Outcomes (2)

• Morisky Medication Adherence Scale-8

  Degree of adherence to prescribed treatment

  2 weeks

• Morisky Medication Adherence Scale-8

  Degree of adherence to prescribed treatment

  4 weeks

Secondary Outcomes (5)

• Patient opinion on Applicator usability

  4 weeks

• Patient overall satisfaction

  4 weeks

• Patient Global Impression of Improvement

  2 weeks

• Patient Global Impression of Improvement

  4 weeks

• Investigator's opinion on the properties of the Applicator

  Baseline

Interventions

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.

Also known as: Daivobet® gel Applicator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Cabinet de Dermatologie, Dr. Mathilde Kemula

Charenton-le-Pont, 94220, France

Location

Related 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. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 BACKGROUND

MeSH Terms

Interventions

calcipotriene

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: August 5, 2016
• Study Start: May 23, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)