Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Bach's Rescue Remedy Cream; Other: Placebo Cream

• Registration Number: NCT00972062
• Lead Sponsor: University of North Carolina, Charlotte

Brief Summary

The purpose of this study is to determine if an herbal over-the-counter cream can decrease skin site reactions in multiple sclerosis patients who currently take either Betaseron, Copaxone or Rebif as their subcutaneous medication for managing their multiple sclerosis. Injection site reactions have been indicated as one of the major reasons for discontinuing treatment with the subcutaneous medications (Betaseron, Copaxone, and Rebif) for multiple sclerosis.

Detailed Description

Skin site reactions account for one of the most likely reasons for discontinuation of subcutaneous injections of MS medications. It is imperative that additional methods be determined to decrease the reactions and/or treat the reactions that occur. Individuals continue to use over the counter preparations (e.g. Benadryl or steroid creams) or other treatments recently described (warm compresses) to improve tolerance to the subcutaneous injections and the reactions. Both short (3 to 6 months) and long term skin reactions have been reported by patients. They complain about this at office visits and calls to nurses in clinics or to those who teach injection technique. Recently, this investigator and a nurse colleague found that an herbal cream (Bach's Rescue Remedy Cream) reduced the redness and skin site reactions. A small investigator funded mini-pilot demonstrated a decrease in resolution and in size of skin site reactions and satisfaction of herbal cream versus the placebo cream. This proposed research study builds upon Moore's previous success that documented significant decrease in injection site reactions by adding an air bubble to the injection before injection, which is now described in the injection instructions of Copaxone, Rebif, and Axonex. The specific hypotheses for this study as end points include:

1. The herbal cream will significantly decrease time of redness based on daily measure of skin site reactions compared to placebo cream.

2. The herbal cream will decrease discomfort of skin site reactions as measured by a visual analogue scale compared to the placebo cream.

3. Participants will indicate how the herbal cream has made a difference to their quality of life based on a qualitative description of effects of skin site reactions before herbal cream and following use of herbal cream

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Participants must demonstrate redness of skin site reactions
• Must demonstrate accurate injection technique prior to initiating the study

Exclusion Criteria

• Cannot read the flexible measure and record the results.
• Are diagnosed with secondary progressive, primary progressive or Devic's MS.
• Are not taking one of the three subcutaneous injections (Betaseron®, Copaxone® or Rebif®).
• Are pregnant.
• Are younger than 18 years of age.
• Are using combination therapy (e.g., 2 of the immunomodulators, chemotherapy)
• Have allergies to any topical creams used on skin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Herbal Cream	Bach's Rescue Remedy Cream	Herbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications
Placebo cream	Placebo Cream	Cream base used in compounding medications into cream media

Primary Outcome Measures

Name	Time	Method
Significant decrease in time and size of redness based on daily measure of skin site reactions using herbal cream compared to placebo cream.	7 days from each injection

Secondary Outcome Measures

Name	Time	Method
Participants will indicate how the herbal cream has made a difference to their quality of life based on a qualitative description of effects of skin site reactions before herbal cream and following use of herbal cream	2 weeks

Trial Locations

Locations (1)

University of North Carolina at Charlotte; 🇺🇸 Charlotte, North Carolina, United States