Psoriasis VulgarisNCT01982552
An Observational Study to Assess Patient Satisfaction and Control of Psoriasis With Calcipotriene/Betamethasone Dipropionate (Taclonex®) Topical Suspension, and Effect on Quality of Life
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 12 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- How many people
- 147 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Academic Alliance Dermatology
Clearwater, Florida, 33756
Dermatology Associates and Research
Coral Gables, Florida, 33134
Melissa Knuckles Dermatology
Corbin, Kentucky, 40701
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, 08520
Center for Dermatology Clinical Research
Fremont, California, 94538
Bettencourt Skin Center
Henderson, Nevada, 89074
Las Vegas Skin and Cancer Clinic
Las Vegas, Nevada, 89128
Skin Specialty Dermatology
New York, New York, 10155
Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032
West End Dermatology
Richmond, Virginia, 23233
Grekin Skin Institute
Warren, Michigan, 48088
Center for Clinical Studies
Webster, Texas, 77598
About this study
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.
- Conditions
- Psoriasis Vulgaris
- Keywords
- Plaque psoriasis, calcipotriene, betamethasone dipropionate, topical
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Life Quality Index (DLQI)
Mean change from baseline
Measured: 8 weeks
Secondary outcomes (5)
Visual Analogue Scale for itching
Mean percent change from baseline
Measured: 2 and 8 weeks
Patient Global Assessment (PGA)
Percent of subjects with controlled disease
Measured: 2 and 8 weeks
Dermatology Life Quality Index (DLQI)
Mean change from baseline
Measured: 2 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)-9
Measured: 2 and 8 weeks
Dermatology Life Quality Index (DLQI)
Percent of patients that have a 5 point or greater change in total score
Measured: 2 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerry Bagel, MD, Principal investigator, Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982552
- Sponsor's protocol ID
- APPEAL
- Status last verified
- Feb 2018
- First submitted
- 6 Nov 2013
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01982552
- Acronym / sponsor ID
- APPEAL
- Conditions
- Psoriasis Vulgaris
- Keywords
- Plaque psoriasis, calcipotriene, betamethasone dipropionate, topical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dermatology Life Quality Index (DLQI)
Time frame: 8 weeks
Mean change from baseline
5 secondary outcomes
Visual Analogue Scale for itching
Time frame: 2 and 8 weeks
Patient Global Assessment (PGA)
Time frame: 2 and 8 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 2 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)-9
Time frame: 2 and 8 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 2 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Result publicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Bagel, MD principal investigator
Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by LEO Pharma at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Life Quality Index (DLQI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.