Reduction of Pain Caused by Biologic Drugs in Psoriasis
Primary Purpose
Psoriasis, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heating Pack
Ice pack
Sponsored by
About this trial
This is an interventional supportive care trial for Psoriasis focused on measuring psoriasis, biologics, subcutaneous, pain, heat, ice
Eligibility Criteria
Inclusion Criteria:
- Patients requiring treatment with a biologic drug
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study-related activity is performed
Exclusion Criteria:
- Patients receiving concurrent therapeutic injections for other indications
- Patients who have taken analgesics within 12 hours of their injection
- A past history of cold-, heat- or pressure-induced urticaria
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Ice pack
Heating Pack
No treatment before injection
Arm Description
Pre-treatment with ice - Ice applied to the skin 2-3 minutes before injecting biologic drug injection
Pre-treatment with heat - Heat applied to the skin 2-3 minutes before injecting biologic drug injection
No treatment applied to the skin 2-3 minutes before injecting biologic drug injection
Outcomes
Primary Outcome Measures
Reduction of pain measured on a visual analogue scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02168244
First Posted
June 18, 2014
Last Updated
May 11, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02168244
Brief Title
Reduction of Pain Caused by Biologic Drugs in Psoriasis
Official Title
Reduction of Injection-related Pain Caused by Subcutaneous Administration of Biologic Drugs in Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Injectable biologic drugs are used as a treatment of psoriasis. These injections can sometimes be associated with pain. In this study the investigators aim to reduce the pain by applying heat or ice to the skin 2-3 minutes before injecting the drug, and to compare the pain to injection without any heat or ice.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Pain
Keywords
psoriasis, biologics, subcutaneous, pain, heat, ice
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ice pack
Arm Type
Active Comparator
Arm Description
Pre-treatment with ice - Ice applied to the skin 2-3 minutes before injecting biologic drug injection
Arm Title
Heating Pack
Arm Type
Active Comparator
Arm Description
Pre-treatment with heat - Heat applied to the skin 2-3 minutes before injecting biologic drug injection
Arm Title
No treatment before injection
Arm Type
No Intervention
Arm Description
No treatment applied to the skin 2-3 minutes before injecting biologic drug injection
Intervention Type
Other
Intervention Name(s)
Heating Pack
Intervention Description
Application of heat to skin for 2-3 minutes prior to injection of biologic drug
Intervention Type
Other
Intervention Name(s)
Ice pack
Intervention Description
Application of cold to skin for 2-3 minutes prior to injection of biologic drug
Primary Outcome Measure Information:
Title
Reduction of pain measured on a visual analogue scale
Time Frame
At time of injection
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients requiring treatment with a biologic drug
Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study-related activity is performed
Exclusion Criteria:
Patients receiving concurrent therapeutic injections for other indications
Patients who have taken analgesics within 12 hours of their injection
A past history of cold-, heat- or pressure-induced urticaria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lebwohl, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Reduction of Pain Caused by Biologic Drugs in Psoriasis
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