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

Completed · Not applicable

Conditions studied: MS (Multiple Sclerosis), Erythema

In brief

Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may cause injection related erythema. This is a randomized controlled cross-over trial of superficial hot and cold modalities to reduce injection site erythema caused by PEG.

Key facts

Study ID: NCT02490943
Run by: Brown, Theodore R., M.D., MPH
People needed: 28
Starts: 2015-06-01
Expected to finish: 2019-04-30
Last updated by the study team: 2022-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Evergreen Health — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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