PsoriasisPhase 4NCT01761019
A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
A Phase 4 study testing Taclonex Topical Suspension in people with Psoriasis, run by University of Pittsburgh at 1 site in United States.
Trial summary
Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective when used as monotherapy (without other oral medicines or creams) than are newer biologic injected drugs. However, these oral medications are also less expensive than biologic agents and may be safer for use in some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Taclonex Topical Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subjects age 18 years and older with stable plaque psoriasis of duration of at least 6 months.
- Subject must be currently using a stable dose, with stable disease severity, of a single non-biologic systemic psoriasis medication (methotrexate or acitretin) for at least 2 months.
- Subject must be planning to continue current systemic agent, and standard of care monitoring for that medication
- All labs required for methotrexate or acitretin will be done according to standard of care.
- If a woman, before entry she must be: Postmenopausal, or practicing a highly effective method of birth control
- Women of childbearing potential must have a negative urine pregnancy test prior to randomization
- Subject must be able and willing to provide written informed consent to participate.
Who cannot join
- Non-plaque psoriasis (pustular, erythrodermic, or guttate).
- Use of excluded therapies: phototherapy use currently or in the 4 weeks prior to baseline, use of more than 1 systemic therapy in the 2 months prior to baseline, use of topical steroid, tar preparation, or vitamin D analog in the 4 weeks prior to baseline.
- Subjects who are currently taking or have taken in the past 60 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
- Subjects with any use at any time in the past of Taclonex topical suspension or Taclonex ointment
- Subjects who are pregnant, nursing, or plan on becoming pregnant during the course of the study.
- Presence of any unstable medical or psychiatric condition that, in the opinion of the investigator, could impair subject compliance.
Show all 10Show fewer
- Subject has any active infection within 30 days prior to baseline.
- Known or suspected disorders of calcium metabolism
- Known or suspected severe kidney or liver disease.
- Known or suspected hypersensitivity to component(s) of the investigational products.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Department of Dermatology, Falk Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Preliminary, Open Label, Single-arm Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective when used as monotherapy (without other oral medicines or creams) than are newer biologic injected drugs. However, these oral medications are also less expensive than biologic agents and may be safer for use in some patients. The purpose of this study is to determine if adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex topical suspension), will improve the severity of psoriasis in patients already on methotrexate or acitretin and to determine if adding this topical suspension will reduce the desire of such patients to switch to a biologic agent to treat their psoriasis.
Read the detailed description
Many patients with mild psoriasis are able to control disease symptoms with topical medications alone. There are a variety of topical options available, including corticosteroids, synthetic vitamin D3, vitamin A, coal tar, salicylic acid and a number of other products of varying efficacy. The combination topical suspension of calcipotriene 0.005% and betamethasone dipropionate 0.064% is a first-line treatment for moderate to severe psoriasis vulgaris and is FDA approved for use on the skin and scalp in adults 18 years and older. This treatment combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is well tolerated and has a low rate of adverse events according to pooled safety data from 2700 patients who have used a calcipotriene/betamethasone combination in clinical trials. Calcipotriene/betamethasone topical suspension has also been shown to have a positive impact on patient quality of life, as seen in clinical trials utilizing patient reported outcomes such as the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index.
Calcipotriene/betamethasone topical suspension is a therapy commonly used to treat patients with mild to moderate psoriasis. Currently, there have been no formal trials studying the efficacy of calcipotriene/betamethasone topical suspension used in conjunction with methotrexate or acitretin. In order to better understand the effectiveness of this treatment combination, we conducted a preliminary, open label, single arm prospective study to determine the benefit of adding betamethasone-calcipotriene topical suspension to ongoing systemic psoriasis therapy in subjects who do not have complete clearance of psoriasis on a single systemic agent alone.
- Conditions
- Psoriasis
- Being tested
- Taclonex Topical Suspension
- Keywords
- psoriasis, Taclonex, Acitretin, Methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taclonex Topical SuspensionDrug
topical medication for psoriasis
| Study group | Role | What they receive |
|---|---|---|
| Taclonex topical suspension | Other | Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks Receives: Drug: Taclonex Topical Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment
This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.
Measured: 12 weeks
Secondary outcomes (4)
Body Surface Area
This is a measure of the percentage of the body involved with psoriasis. We will measure the change in percentage of body area involved with psoriasis from baseline to week 12.
Measured: 12 weeks
Safety
Throughout this study, adverse events and serious adverse events will be collected
Measured: 12 weeks
Patient Satisfaction
- Subject satisfaction: We also ask subjects for their level of satisfaction with their current treatment at week 12. They will be given the following options: "very satisfied", "satisfied", "somewhat disappointed" or "very disappointed". For measurement "very satisfied"=4, "satisfied"=3, "somewhat disappointed"=2 and "very disappointed"=1. We will determine the mean satisfaction of all patients at week 12.
Measured: 12 weeks
Desire to Change to Another Systemic Therapy
We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, Laura Ferris, University of Pittsburgh
- Investigators
- Laura Ferris, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761019
- Sponsor's protocol ID
- PRO12100308
- Status last verified
- Aug 2016
- First submitted
- 2 Jan 2013
- Last updated
- 21 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ferris LK, Kupetsky E, Houston NA. A Preliminary, Open Label, Single-arm Study of Calcipotriene/Betamethasone Topical Suspension as a Supplement to Non-biologic Systemic Therapy for Psoriasis. J Clin Aesthet Dermatol. 2016 Apr;9(4):33-8. Epub 2016 Apr 1.
PubMed 27462386
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary, Open Label, Single-arm Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
- ClinicalTrials.gov ID
- NCT01761019
- Acronym / sponsor ID
- PRO12100308
- Conditions
- Psoriasis
- Keywords
- psoriasis, Taclonex, Acitretin, Methotrexate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Posted 21 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective when used as monotherapy (without other oral medicines or creams) than are newer biologic injected drugs. However, these oral medications are also less expensive than biologic agents and may be safer for use in some patients. The purpose of this study is to determine if adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex topical suspension), will improve the severity of psoriasis in patients already on methotrexate or acitretin and to determine if adding this topical suspension will reduce the desire of such patients to switch to a biologic agent to treat their psoriasis.
Detailed description
Many patients with mild psoriasis are able to control disease symptoms with topical medications alone. There are a variety of topical options available, including corticosteroids, synthetic vitamin D3, vitamin A, coal tar, salicylic acid and a number of other products of varying efficacy. The combination topical suspension of calcipotriene 0.005% and betamethasone dipropionate 0.064% is a first-line treatment for moderate to severe psoriasis vulgaris and is FDA approved for use on the skin and scalp in adults 18 years and older. This treatment combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is well tolerated and has a low rate of adverse events according to pooled safety data from 2700 patients who have used a calcipotriene/betamethasone combination in clinical trials. Calcipotriene/betamethasone topical suspension has also been shown to have a positive impact on patient quality of life, as seen in clinical trials utilizing patient reported outcomes such as the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index.
Calcipotriene/betamethasone topical suspension is a therapy commonly used to treat patients with mild to moderate psoriasis. Currently, there have been no formal trials studying the efficacy of calcipotriene/betamethasone topical suspension used in conjunction with methotrexate or acitretin. In order to better understand the effectiveness of this treatment combination, we conducted a preliminary, open label, single arm prospective study to determine the benefit of adding betamethasone-calcipotriene topical suspension to ongoing systemic psoriasis therapy in subjects who do not have complete clearance of psoriasis on a single systemic agent alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taclonex topical suspension | Other | Drug: Taclonex Topical SuspensionTaclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects age 18 years and older with stable plaque psoriasis of duration of at least 6 months.
- Subject must be currently using a stable dose, with stable disease severity, of a single non-biologic systemic psoriasis medication (methotrexate or acitretin) for at least 2 months.
- Subject must be planning to continue current systemic agent, and standard of care monitoring for that medication
- All labs required for methotrexate or acitretin will be done according to standard of care.
- If a woman, before entry she must be: Postmenopausal, or practicing a highly effective method of birth control
Key exclusion criteria (10 listed)
- Non-plaque psoriasis (pustular, erythrodermic, or guttate).
- Use of excluded therapies: phototherapy use currently or in the 4 weeks prior to baseline, use of more than 1 systemic therapy in the 2 months prior to baseline, use of topical steroid, tar preparation, or vitamin D analog in the 4 weeks prior to baseline.
- Subjects who are currently taking or have taken in the past 60 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
- Subjects with any use at any time in the past of Taclonex topical suspension or Taclonex ointment
- Subjects who are pregnant, nursing, or plan on becoming pregnant during the course of 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taclonex Topical Suspensiontopical medication for psoriasis | Drug | Taclonex topical suspension |
Primary outcome
Investigator Global Assessment
Time frame: 12 weeks
This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.
4 secondary outcomes
Body Surface Area
Time frame: 12 weeks
Safety
Time frame: 12 weeks
Patient Satisfaction
Time frame: 12 weeks
Desire to Change to Another Systemic Therapy
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27462386Ferris LK, Kupetsky E, Houston NA. A Preliminary, Open Label, Single-arm Study of Calcipotriene/Betamethasone Topical Suspension as a Supplement to Non-biologic Systemic Therapy for Psoriasis. J Clin Aesthet Dermatol. 2016 Apr;9(4):33-8. Epub 2016 Apr 1.
- UPMC Dermatology Clinical TrialsLink 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.
Laura Ferris, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Taclonex Topical Suspension in people with Psoriasis, run by University of Pittsburgh at 1 site 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 7 inclusion and 10 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Investigator Global Assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761019, which also lists 1 linked publication.
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 21 Sep 2016.