Reduction of Pain Caused by Biologic Drugs in Psoriasis

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.

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Key information

Conditions

Psoriasis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heating Pack

Other

Application of heat to skin for 2-3 minutes prior to injection of biologic drug

ice pack

Other

Application of cold to skin for 2-3 minutes prior to injection of biologic drug

Primary outcomes

Reduction of pain measured on a visual analogue scale

Time frame: At time of injection

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Reduction of Injection-related Pain Caused by Subcutaneous Administration of Biologic Drugs in Psoriasis

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jun 20, 2014
Registry last updated: May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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