NCT00988988

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	AGEE cream	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.
DRUG	1% Steroid Cream	comparing to AGEE cream or placebo. 1% steroid cream is available over the counter. To be used immediately after injection and as needed.
DRUG	topical placebo cream with no active ingredients	Cream to be applied immediately after injection and repeated as needed.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-08-03
• Completion: 2012-08-03
• First posted: 2009-10-02
• Last updated: 2023-08-23