Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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: The herbal cream will significantly decrease time of redness based on daily measure of skin site reactions compared to placebo cream. The herbal cream will decrease discomfort of skin site reactions as measured by a visual analogue scale compared to the placebo cream. 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

Official Title
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Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Bach's Rescue Remedy Cream
* Other: Placebo Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo cream<br>Cream base used in compounding medications into cream media | Other: Placebo Cream<br>* Placebo cream 0.5 ml two times a day as needed<br>* Other names: Base cream;|
| Experimental: Herbal Cream<br>Herbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications | Other: Bach's Rescue Remedy Cream<br>* 0.5 ml of cream applied to skin site reactions as needed<br>* Other names: Rescue Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subcutaneous injections, Skin abnormalities