Reduction of Pain Caused by Biologic Drugs in Psoriasis

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).

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