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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
  • Florida
    • Clearwater, Florida, United States, 33756
      • Academic Alliance Dermatology
    • Coral Gables, Florida, United States, 33134
      • Dermatology Associates and Research
  • Kentucky
    • Corbin, Kentucky, United States, 40701
      • Melissa Knuckles Dermatology
  • Michigan
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Bettencourt Skin Center
    • Las Vegas, Nevada, United States, 89128
      • Las Vegas Skin and Cancer Clinic
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central NJ
  • New York
    • New York, New York, United States, 10155
      • Skin Specialty Dermatology
  • Texas
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Virginia
    • Richmond, Virginia, United States, 23233
      • West End Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Life Quality Index (DLQI)	Mean change from baseline	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Jerry Bagel, MD, Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ

Publications and helpful links

Helpful Links

• Result publication

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: topical; Plaque psoriasis; calcipotriene; betamethasone dipropionate
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: APPEAL