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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01982552

Enrollment

147

Registered

2013-11-13

Start date

2013-07-31

Completion date

2014-01-31

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

Keywords

Plaque psoriasis, calcipotriene, betamethasone dipropionate, topical

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 weeks	Mean change from baseline
Treatment Satisfaction Questionnaire for Medication (TSQM)-9	2 and 8 weeks	—

Countries

United States

Outcome results