A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | September 2014 |
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, 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.
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, 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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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