A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS

The most common adverse event associated with this subcutaneously (SC) injected drug is
injection site reaction (ISR) including redness and pain.Theoretically, both heat and cold
modalities may improve interferon injection tolerance. Warm compress before injection may
increase local blood flow and increase rapid systemic absorption, while cold compress
afterward may reduce the erythema, edema and pain that often follow SC injections. A trial
comparing heat-before and cold-after therapy is warranted to determine the relative
effectiveness of these modalities.

Intervention:

Product: Reusable cold and warm compress.

Patients will receive written instructions for microwave heating and freezer cooling of the
compress.

Warm compress: Pre-heating in microwave oven, per instructions. Apply warm compress for 5
minutes prior to injection. The initial compress temperature will be about 43 degrees Celsius
(range 40-46 degrees Celsius) and slowly decline during application. Administer drug soon
after removal.

Cold compress: Cooling in a freezer as per instructions. Soon after drug injection, apply
cold compress for 10 minutes. The initial compress temperature will range 15-18 degrees
Celsius.

- Timers will be utilized to mark 5-minute and 10-minute treatment intervals

- Participants will be encouraged to maintain constant practices with regards to
non-steroidal anti-inflammatory drug use during the study

Study Objectives:

1. To assess and compare the impact on erythema of two thermal treatments: warm compress
prior to PEG injection and cold compress following PEG injection

2. To assess the natural history of PEG-erythema over time. This will be accomplished with
18 weeks of observation in the control group.

Inclusion Criteria:

- Diagnosis of MS made at least 3 months prior based on McDonald criteria.

- Age 18 or more

- Ongoing treatment with PEG for 30 days or more at screening

- No MS exacerbation for 60 days prior to screening.

- Score of ≥50 on screening ISR Erythema Index

- Home access to microwave oven and freezer

- Written informed consent

Exclusion Criteria:

- Any contraindication to warm or cold compress:

- Inability to sense temperature change by patient report

- Metal implant near injection site (e.g. injection near intra-abdominal baclofen
pump)

- History of allergy or intolerance to local heat or cold application

- Bleeding disorder

- Concomitant use of any topical prescription medication at injection site

- Females who are breast-feeding, pregnant or have potential to become pregnant during
the course of the study (fertile and unwilling/unable to use effective contraceptive
measures)

- Cognitive deficits that would interfere with the subject's ability to give informed
consent or perform study testing.

- Any other serious and/or unstable medical condition