NCT00972062

Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of North Carolina, Charlotte · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Bach's Rescue Remedy Cream	0.5 ml of cream applied to skin site reactions as needed
OTHER	Placebo Cream	Placebo cream 0.5 ml two times a day as needed

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2009-09-04
• Last updated: 2012-03-07

Locations

1 site across 1 country: United States