Reduction of Pain Caused by Biologic Drugs in Psoriasis
Reduction of Injection-related Pain Caused by Subcutaneous Administration of Biologic Drugs in Psoriasis
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMay 13, 2016
May 1, 2016
1.8 years
June 18, 2014
May 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of pain measured on a visual analogue scale
At time of injection
Study Arms (3)
Ice pack
ACTIVE COMPARATORPre-treatment with ice - Ice applied to the skin 2-3 minutes before injecting biologic drug injection
Heating Pack
ACTIVE COMPARATORPre-treatment with heat - Heat applied to the skin 2-3 minutes before injecting biologic drug injection
No treatment before injection
NO INTERVENTIONNo treatment applied to the skin 2-3 minutes before injecting biologic drug injection
Interventions
Application of heat to skin for 2-3 minutes prior to injection of biologic drug
Application of cold to skin for 2-3 minutes prior to injection of biologic drug
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Lebwohl, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 20, 2014
Study Start
May 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
May 13, 2016
Record last verified: 2016-05