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Clinical Trials/NCT01982552
NCT01982552
Completed
N/A

An Observational Study to Assess Patient Satisfaction and Control of Psoriasis With Calcipotriene/Betamethasone Dipropionate (Taclonex®) Topical Suspension, and Effect on Quality of Life

LEO Pharma12 sites in 1 country147 target enrollmentJuly 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psoriasis Vulgaris
Sponsor
LEO Pharma
Enrollment
147
Locations
12
Primary Endpoint
Dermatology Life Quality Index (DLQI)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to document quality of life, patient satisfaction, effect on itching, and control of psoriasis vulgaris associated with use of calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension 0.005% / 0.064% for treatment of plaque psoriasis under real-life conditions.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
January 2014
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
LEO Pharma
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Signed and dated informed consent obtained prior to any study related activities
  • Aged 18 years or above
  • Any race or ethnicity
  • Attending a hospital outpatient clinic or the private practice of a board-certified dermatologist, dermatology-certified nurse practitioner or physician assistant trained in dermatology
  • Clinical diagnosis of psoriasis vulgaris involving scalp and/or body amenable to treatment with a maximum of 100 g of topical medication per week.
  • Patients who receive a prescription of calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension 0.005% / 0.064% as per an investigator's clinical judgment and in accordance with the US label, and who have access to the medication
  • Able to communicate with the investigator, read and understand English, and understand and comply with the requirements of the study

Exclusion Criteria

  • Prior treatment with calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension, 0.005%/0.064%.
  • Contraindications or any warnings/precautions according to the US label.
  • Current participation in any other interventional clinical study.
  • Females who are pregnant, breast-feeding, or females of child-bearing potential wishing to become pregnant during the study.

Outcomes

Primary Outcomes

Dermatology Life Quality Index (DLQI)

Time Frame: 8 weeks

Mean change from baseline

Secondary Outcomes

  • Visual Analogue Scale for itching(2 and 8 weeks)
  • Patient Global Assessment (PGA)(2 and 8 weeks)
  • Dermatology Life Quality Index (DLQI)(2 and 8 weeks)
  • Treatment Satisfaction Questionnaire for Medication (TSQM)-9(2 and 8 weeks)

Study Sites (12)

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