Topical Psoriasis Study for Patients Receiving Biologic Therapy
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|ClinicalTrials.gov Identifier: NCT02983981|
Recruitment Status : Completed
First Posted : December 6, 2016
Results First Posted : May 7, 2018
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Topicort Topical Spray||Phase 4|
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks.
Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients will receive Topicort® BID for 4 weeks.
After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||October 2016|
Experimental: open label
Topicort topical spray
Drug: Topicort Topical Spray
open label Topicort spray
- Psoriasis Severity [ Time Frame: 16 weeks ]Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.
- Psoriasis Severity [ Time Frame: 16 weeks ]Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis
- Psoriasis Severity [ Time Frame: 16 weeks ]Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.
- Dermatology Life Quality Index [ Time Frame: 16 weeks ]calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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): NCT02983981
|Principal Investigator:||Jerry Bagel, MD||Director|