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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alliance Dermatology and Mohs Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed and dated informed consent obtained prior to any study related activities
  • Aged 18 years or above
  • Either sex
  • Any race or ethnicity
  • Attending a hospital outpatient clinic or the private practice of a board-certified dermatologist, dermatology-certified nurse practitioner or physician assistant trained in dermatology
  • Clinical diagnosis of psoriasis vulgaris involving scalp and/or body amenable to treatment with a maximum of 100 g of topical medication per week.
  • 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
  • Able to communicate with the investigator, read and understand English, and understand and comply with the requirements of the study

Exclusion criteria

  • Prior treatment with calcipotriene/betamethasone dipropionate (Taclonex®) topical suspension, 0.005%/0.064%.
  • Contraindications or any warnings/precautions according to the US label.
  • Current participation in any other interventional clinical study.
  • Females who are pregnant, breast-feeding, or females of child-bearing potential wishing to become pregnant during the study.

Treatment and study plan

Primary outcomes

  1. Dermatology Life Quality Index (DLQI)

    Time frame: 8 weeks

    Mean change from baseline

Secondary outcomes

  1. Visual Analogue Scale for itching

    Time frame: 2 and 8 weeks

    Mean percent change from baseline

  2. Patient Global Assessment (PGA)

    Time frame: 2 and 8 weeks

    Percent of subjects with controlled disease

  3. Dermatology Life Quality Index (DLQI)

    Time frame: 2 weeks

    Mean change from baseline

  4. Treatment Satisfaction Questionnaire for Medication (TSQM)-9

    Time frame: 2 and 8 weeks

  5. Dermatology Life Quality Index (DLQI)

    Time frame: 2 and 8 weeks

    Percent of patients that have a 5 point or greater change in total score

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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