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Reduction of Pain Caused by Biologic Drugs in Psoriasis

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ClinicalTrials.gov Identifier: NCT02168244
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Psoriasis Pain Other: Heating Pack Other: Ice pack Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Reduction of pain measured on a visual analogue scale [ Time Frame: At time of injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02168244


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02168244    
Other Study ID Numbers: GCO 14-0535
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by Icahn School of Medicine at Mount Sinai:
psoriasis
biologics
subcutaneous
pain
heat
ice
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases