Real-life Evaluation of the Daivobet® Gel Applicator

NCT ID: NCT02856542

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-23

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Plaque Psoriasis

Keywords

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Psoriasis vulgaris, scalp, topical, applicator, device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Daivobet® gel Applicator

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathilde Kemula, MD

Role: PRINCIPAL_INVESTIGATOR

Cabinet de Dermatologie, Dr. Mathilde Kemula

Frederic Bonnier, MD

Role: PRINCIPAL_INVESTIGATOR

General Practice, 356 Rue de Charles de Gaulle, 91400 Orsay

Nathalie Quiles, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Joseph, 26 Boulevard de Louvain, Marseille

Locations

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Cabinet de Dermatologie, Dr. Mathilde Kemula

Charenton-le-Pont, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 3945130 (View on PubMed)

Other Identifiers

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NIS-DAIVOBETGEL-1284

Identifier Type: -

Identifier Source: org_study_id