Reduction of Pain Caused by Biologic Drugs in Psoriasis
|ClinicalTrials.gov Identifier: NCT02168244|
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Pain||Other: Heating Pack Other: Ice pack||Not Applicable|
As part of their therapy, some patients with psoriasis require treatment with biologic drugs, which are injected into their skin. While these are very effective, patients may experience some pain or discomfort associated with the injection of these drugs.
In this research study conducted at Mount Sinai hospital, the investigators aim to identify whether this injection-related pain can be reduced if the area of skin to be injected with the biologic drug is treated with either ice packs or heating for two to three minutes prior to the injection.
The investigators' aim is to include a total of 110 patients into this study, who have been started by their physician on one of these biologic drugs, such as etanercept, adalimumab, ustekinumab, or receiving secukinumab as part of a research study. Patients will be recruited at the Dermatology department. Patients who are receiving a biologic drug, which is injected subcutaneously (into their skin) are eligible to participate in this study.
Each patient will receive his/her injection at our study site, by a study doctor/investigator. The same designee should inject the subject all three times. Each patient will receive a total of three of their biologic drug injections at the study site, so he/she can receive the injection once following pre-treatment with ice, once following pre-treatment with heating, and once without any pre-treatment.
Patients will then be asked to mark the intensity of the pain associated with the injection on a scale, consisting of a horizontal line, by placing a single mark on the scale. The order of pre-treatment with ice or heat, or no pre-treatment will be randomized among all subjects (1/3 will receive ice first, 1/3 will receive heat first, 1/3 will receive no treatment first; the same randomization ratio will apply for the second and third injections).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Reduction of Injection-related Pain Caused by Subcutaneous Administration of Biologic Drugs in Psoriasis|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: Ice pack
Pre-treatment with ice - Ice applied to the skin 2-3 minutes before injecting biologic drug injection
Other: Ice pack
Application of cold to skin for 2-3 minutes prior to injection of biologic drug
Active Comparator: Heating Pack
Pre-treatment with heat - Heat applied to the skin 2-3 minutes before injecting biologic drug injection
Other: Heating Pack
Application of heat to skin for 2-3 minutes prior to injection of biologic drug
No Intervention: No treatment before injection
No treatment applied to the skin 2-3 minutes before injecting biologic drug injection
- Reduction of pain measured on a visual analogue scale [ Time Frame: At time of injection ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168244
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Mark Lebwohl, MD||Icahn School of Medicine at Mount Sinai|