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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2014

Clinical Trial Outcome Measures

Primary Measures

  • Dermatology Life Quality Index (DLQI)
    • Time Frame: 8 weeks
    • Mean change from baseline

Secondary Measures

  • Visual Analogue Scale for itching
    • Time Frame: 2 and 8 weeks
    • Mean percent change from baseline
  • Patient Global Assessment (PGA)
    • Time Frame: 2 and 8 weeks
    • Percent of subjects with controlled disease
  • Dermatology Life Quality Index (DLQI)
    • Time Frame: 2 weeks
    • Mean change from baseline
  • Treatment Satisfaction Questionnaire for Medication (TSQM)-9
    • Time Frame: 2 and 8 weeks
  • Dermatology Life Quality Index (DLQI)
    • Time Frame: 2 and 8 weeks
    • Percent of patients that have a 5 point or greater change in total score

Participating in This Clinical Trial

Inclusion Criteria

1. Signed and dated informed consent obtained prior to any study related activities

2. Aged 18 years or above

3. Either sex

4. Any race or ethnicity

5. Attending a hospital outpatient clinic or the private practice of a board-certified dermatologist, dermatology-certified nurse practitioner or physician assistant trained in dermatology

6. Clinical diagnosis of psoriasis vulgaris involving scalp and/or body amenable to treatment with a maximum of 100 g of topical medication per week.

7. 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

8. Able to communicate with the investigator, read and understand English, and understand and comply with the requirements of the study

Exclusion Criteria

1. Prior treatment with calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension, 0.005%/0.064%.

2. Contraindications or any warnings/precautions according to the US label.

3. Current participation in any other interventional clinical study.

4. Females who are pregnant, breast-feeding, or females of child-bearing potential wishing to become pregnant during the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jerry Bagel, MD, Principal Investigator, Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ

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