Clinical trial NCT01982552: An Observational Study to Assess Patient Satisfaction and Control of Psoriasis With Calcipotriene/Betamethasone Dipropionate (Taclonex®) Topical Suspension, and Effect on Quality of Life
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Keywords: Plaque psoriasis
calcipotriene
betamethasone dipropionate
topical
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual Analogue Scale for itching
timeFrame: 2 and 8 weeks
measure: Patient Global Assessment (PGA)
timeFrame: 2 and 8 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 2 weeks
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)-9
timeFrame: 2 and 8 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 2 and 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Clearwater
country: United States
facility: Academic Alliance Dermatology
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Corbin
country: United States
facility: Melissa Knuckles Dermatology
state: Kentucky
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Henderson
country: United States
facility: Bettencourt Skin Center
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Skin and Cancer Clinic
state: Nevada
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central NJ
state: New Jersey
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Richmond
country: United States
facility: West End Dermatology
state: Virginia
Study officials:
affiliation: Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ
name: Jerry Bagel, MD
role: PRINCIPAL_INVESTIGATOR
References: