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

NCT01707368 | Completed Results

• 1 other identifier: DE-Daivobet-longterm-NIS-2012
• Study Type: observational
• Target: 561
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis Vulgaris; Plaque Psoriasis

Keywords

Psoriasis; Psoriasis vulgaris; Plaque Psoriasis; Daivobet® Gel; Germany

Outcome Measures

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.

  Number of exacerbations and relapses during one year observation time

  1 year

Secondary Outcomes (3)

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

  Baseline

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

  1 year

• Side Effects

  1 year

Study Arms (1)

all eligible patients

Daivobet® Gel 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.

Drug: Daivobet® Gel

Interventions

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.

all eligible patients

Eligibility Criteria

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

Study Population

Patients with Psoriasis vulgaris visiting their attending dermatologist in the primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

PD Dr. med. Rosenbach

Osnabrück, Lower Saxony, 49078, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Mean duration of observation per patients: Mean (SD): 40.47 (17.60) weeks.

Results Point of Contact

• Title: Tobias Anger, Medical Advisor
• Organization: LEO Pharma GmbH

TANDE@leo-pharma.com

+49 610 220 1258

Study Officials

• Thomas Rosenberg, PD Dr. med.

  private practise, D- 49078 Osnabrück, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 24, 2018
• Results First Posted: September 24, 2018

Record last verified: 2018-01

Locations

DE (1)