A Study to Determine the Efficacy of Taclonex Topical Suspension as a Supplement to Non-biologic Systemic Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Investigator Global Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Body Surface Area [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Throughout this study, adverse events and serious adverse events will be collected
- Patient Satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]• 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.
- Desire to Change to Another Systemic Therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.
|Study Start Date:||January 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Taclonex topical suspension
Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Drug: Taclonex Topical Suspension
topical medication for psoriasis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761019
|United States, Pennsylvania|
|UPMC Department of Dermatology, Falk Clinic|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Laura Ferris, MD, PhD||University of Pittsburgh|