Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MSSkin  

Official title:

Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972062
• Other study ID #: TEVA 540837
• Status: Completed
• Phase: N/A
• First received: September 2, 2009
• Last updated: March 6, 2012
• Start date: June 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: University of North Carolina, Charlotte
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Bach's Rescue Remedy Cream
0.5 ml of cream applied to skin site reactions as needed
• Placebo Cream
Placebo cream 0.5 ml two times a day as needed

Locations

Country	Name	City	State
United States	University of North Carolina at Charlotte	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Charlotte	Teva Pharmaceutical Industries

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses. Mult Scler. 1998 Apr;4(2):70-3. — View Citation

Halper J, Harris C, Machler B. Manageing injection-site reactions in patients with MS. Multiple Sclerosis Counseling Points 1:1-10,2005

Jolly H, Simpson K, Bishop B, Hunter H, Newell C, Denney D, Oleen-Burkey M. Impact of warm compresses on local injection-site reactions with self-administered glatiramer acetate. J Neurosci Nurs. 2008 Aug;40(4):232-9. — View Citation

Moore LA, Kaufman MD, Algozzine R, Irish N, Martin M, Posey CR. Adherence to therapy: using an evidence-based protocol. Rehabil Nurs. 2007 Nov-Dec;32(6):227-32. — View Citation

Samuel L, Lowenstein EJ. Recurrent injection site reactions from interferon beta 1-b. J Drugs Dermatol. 2006 Apr;5(4):366-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No