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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982552
• Other study ID #: APPEAL
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: February 1, 2018
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Locations

Country	Name	City	State
United States	Academic Alliance Dermatology	Clearwater	Florida
United States	Dermatology Associates and Research	Coral Gables	Florida
United States	Melissa Knuckles Dermatology	Corbin	Kentucky
United States	Psoriasis Treatment Center of Central NJ	East Windsor	New Jersey
United States	Center for Dermatology Clinical Research	Fremont	California
United States	Bettencourt Skin Center	Henderson	Nevada
United States	Las Vegas Skin and Cancer Clinic	Las Vegas	Nevada
United States	Skin Specialty Dermatology	New York	New York
United States	Alliance Dermatology and Mohs Center	Phoenix	Arizona
United States	West End Dermatology	Richmond	Virginia
United States	Grekin Skin Institute	Warren	Michigan
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Result publication