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

University of Nebraska

Status and phase: Withdrawn; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: AGEE cream; Drug: 1% Steroid Cream; Drug: topical placebo cream with no active ingredients

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00988988

0399-09-FB

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Steroid Cream

Active Comparator group

Description:

1% steroid cream

Treatment:

Drug: 1% Steroid Cream

AGEE cream

Active Comparator group

Description:

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

Treatment:

Drug: AGEE cream

placebo

Active Comparator group

Description:

inactive cream

Treatment:

Drug: topical placebo cream with no active ingredients