A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00220922

Enrollment

Registered

2005-09-22

Start date

2004-08-31

Completion date

2006-02-28

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Copaxone

Brief summary

This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

Interventions

PROCEDUREAlcohol Wipes vs. No Alcohol Wipes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or Female * 18 years of age or older * Diagnosis of RRMS * Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously

Exclusion criteria

* Unable to perform subcutaneous self-injection * Pregnant, or trying to become pregnant, or breast feeding during the study

Design outcomes

Primary

Measure	Time frame
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection	four weeks of Period 1 and the four weeks of Period 2

Secondary

Measure	Time frame
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection	four weeks of Period 1 and the four weeks of Period 2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026