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

Erythema Clinical Trial

— PEG-Thermal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490943
• Other study ID #: TRB2015
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: January 2019
• Source: Brown, Theodore R., M.D., MPH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 30, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• MS (Multiple Sclerosis)
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Warm Compress Before Injection
Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.
• Cold Compress After Injection
Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.

Locations

Country	Name	City	State
United States	Evergreen Health	Kirkland	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Brown, Theodore R., M.D., MPH	Evergreen Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks.	Participants will record the diameter of patch of skin discoloration in millimeters, measuring at the maximum width.	24 hours, 7 days, 14 days
Secondary	Change from baseline in rating of Modified Local Injection Site Reaction Scale		24 hours
Secondary	Erythema score on the Visual Assessment Scale.	This is a 5 point visual assessment scale. Participants will be asked to observe the change in skin color at the site of injection. They will rate the intensity of skin color change (erythema) using the scale below. These assessments will be recorded at the following time points: 24 hours, 7 days, and 14 days	Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
Secondary	Pain score on the visual analogue scale after 10-minutes.	(post-injection, 0-10 visual analogue scale (VAS))	10 min.
Secondary	Pain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days	(post-injection, 0-10 visual analogue scale (VAS))	Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
Secondary	Level of Comfort Post-Injection Impression of Last 3 Weeks.	This is a single question: "How would you rate your level of comfort with the last three injections?" This is on a 0-10 VAS with 0= "extremely bad" 5="neither good nor bad" and 10= "extremely good." The question will be answered at the end of each phase of the study.	18 Weeks