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

Completed

• Conditions: Psoriasis Vulgaris

• Registration Number: NCT01982552
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-13
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI)	8 weeks	Mean change from baseline

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Grekin Skin Institute; 🇺🇸 Warren, Michigan, United States

Center for Dermatology Clinical Research; 🇺🇸 Fremont, California, United States

Psoriasis Treatment Center of Central NJ; 🇺🇸 East Windsor, New Jersey, United States

Academic Alliance Dermatology; 🇺🇸 Clearwater, Florida, United States

Dermatology Associates and Research; 🇺🇸 Coral Gables, Florida, United States

Center for Clinical Studies; 🇺🇸 Webster, Texas, United States

Skin Specialty Dermatology; 🇺🇸 New York, New York, United States

Alliance Dermatology and Mohs Center; 🇺🇸 Phoenix, Arizona, United States

Las Vegas Skin and Cancer Clinic; 🇺🇸 Las Vegas, Nevada, United States

Bettencourt Skin Center; 🇺🇸 Henderson, Nevada, United States

Melissa Knuckles Dermatology; 🇺🇸 Corbin, Kentucky, United States

West End Dermatology; 🇺🇸 Richmond, Virginia, United States