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

NCT02490943 | Completed

• 1 other identifier: TRB2015
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MS (Multiple Sclerosis); Erythema

Keywords

peginterferon beta-1a; MS (Multiple Sclerosis); Injection Site Reaction Erythema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in rating of Modified Local Injection Site Reaction Scale

  24 hours

• Erythema score on the Visual Assessment Scale.

  Change from Baseline in VAS at 24 hours, 7 days, and 14 days.

• Pain score on the visual analogue scale after 10-minutes.

  10 min.

• Pain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days

  Change from Baseline in VAS at 24 hours, 7 days, and 14 days.

• Level of Comfort Post-Injection Impression of Last 3 Weeks.

  18 Weeks

Study Arms (3)

Warm Compress Pre-Injection

ACTIVE COMPARATOR

Group A, N = 10, will receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.

Other: Warm Compress Before Injection

Cold Compress Post-Injection

ACTIVE COMPARATOR

Group B, N= 10, will receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.

Other: Cold Compress After Injection

No Intervention Pre/Post-Injection

NO INTERVENTION

Group C, N= 8, will receive no treatment for six injections following screening.

Interventions

Warm Compress Before Injection OTHER

Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.

Also known as: Group A

Warm Compress Pre-Injection

Cold Compress After Injection OTHER

Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.

Also known as: Group B

Cold Compress Post-Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brown, Theodore R., M.D., MPH: lead
• Evergreen Healthcare: collaborator

Study Sites (1)

Evergreen Health

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Erythema

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Theodore R Brown, M.D., MPH

  Evergreen Health Nueroscience Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: Participants were randomized to warm compress (WC) for three injections, followed by cold compress (CC) for three injections, CC followed by WC, each for three injections or no treatment for six injections

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 7, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: April 30, 2019
• Last Updated: March 25, 2022

Record last verified: 2019-01

Locations

US (1)