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Trial record 57 of 272 for:    Betamethasone

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

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ClinicalTrials.gov Identifier: NCT01982552
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Psoriasis Vulgaris

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Study Type : Observational
Actual Enrollment : 147 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : July 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014





Primary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI) [ Time Frame: 8 weeks ]
    Mean change from baseline


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982552


Locations
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United States, Arizona
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States, 85032
United States, California
Center for Dermatology Clinical Research
Fremont, California, United States, 94538
United States, Florida
Academic Alliance Dermatology
Clearwater, Florida, United States, 33756
Dermatology Associates and Research
Coral Gables, Florida, United States, 33134
United States, Kentucky
Melissa Knuckles Dermatology
Corbin, Kentucky, United States, 40701
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Nevada
Bettencourt Skin Center
Henderson, Nevada, United States, 89074
Las Vegas Skin and Cancer Clinic
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, United States, 08520
United States, New York
Skin Specialty Dermatology
New York, New York, United States, 10155
United States, Texas
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Virginia
West End Dermatology
Richmond, Virginia, United States, 23233
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Jerry Bagel, MD Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ

Additional Information:
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01982552     History of Changes
Other Study ID Numbers: APPEAL
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Keywords provided by LEO Pharma:
Plaque psoriasis
calcipotriene
betamethasone dipropionate
topical
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents