The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections

Study Overview
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Brief Summary
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Participants with multiple sclerosis that are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site will be recruited to examine histamine response of three topical treatments to reduce these symptoms.

Detailed Description
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Participants are asked to be in this study because they have multiple sclerosis, are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site. The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by redness, swelling, and itch response following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple Sclerosis (MS).

Official Title
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The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: AGEE cream
* Drug: 1% Steroid Cream
* Drug: topical placebo cream with no active ingredients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed consent Between ages 19-65 Laboratory supported diagnosis of multiple sclerosis Currently treated with injectable GA, experiencing wheal and flare after injection Exclusion Criteria: Unable to give informed consent Treated with any other therapy for Multiple Sclerosis

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid Cream<br>1% steroid cream | Drug: 1% Steroid Cream<br>* comparing to AGEE cream or placebo. 1% steroid cream is available over the counter. To be used immediately after injection and as needed.<br>* Other names: generic;|
| Active Comparator: AGEE cream<br>AGEE cream is a creatine ethyl ester based product (an amino acid) that can be purchased over-the-counter without a prescription and is not FDA controlled | Drug: AGEE cream<br>* AGEE cream is a creatine ethyl ester based product (an amino acid) that can be purchased over-the-counter without a prescription and is not FDA controlled. It will be used immediately after injection and repeated as needed.<br>* Other names: creatine ethyl ester based topical;|
| Active Comparator: placebo<br>inactive cream | Drug: topical placebo cream with no active ingredients<br>* Cream to be applied immediately after injection and repeated as needed.<br>* Other names: generic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histamine response after ethyl-α-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate | To determine if the use of ethyl-α-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by wheal, flare and itch response following subcutaneous injection of glatiramer acetate for the treatment of Multiple Sclerosis | Three weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, AGEE, histamine response