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Completed

NCT Number: NCT01707368

Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation

The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.

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Key information

Conditions

Psoriasis Vulgaris Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PD Dr. med. Rosenbach

Osnabrück, Lower Saxony, 49078, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway.
  • Minimum of 3 years diagnosed psoriasis vulgaris.

Exclusion criteria

  • Previous therapy with Daivobet® Gel
  • Systemic therapy of psoriasis vulgaris
  • Contraindications of Daivobet® Gel in the German package insert
  • people that are incapable to give free consent

Treatment and study plan

Daivobet® Gel

Drug

Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.

Primary outcomes

  1. The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.

    Time frame: 1 year

    Number of exacerbations and relapses during one year observation time

Secondary outcomes

  1. PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)

    Time frame: Baseline

    6--point verbal rating scale

  2. PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)

    Time frame: 1 year

    Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)

  3. Side Effects

    Time frame: 1 year

    Number of participants with serious and non-serious adverse drug reactions.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

Course of Psoriasis During Long Term Treatment With Calcipotriol Plus Betamethasone in Gel Formulation

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 16, 2012
Registry last updated
Sep 24, 2018

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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