Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

NCT ID: NCT00972062

Last Updated: 2012-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo cream

Cream base used in compounding medications into cream media

Group Type: PLACEBO_COMPARATOR

Placebo Cream

Intervention Type: OTHER

Placebo cream 0.5 ml two times a day as needed

Herbal Cream

Herbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications

Group Type: EXPERIMENTAL

Bach's Rescue Remedy Cream

Intervention Type: OTHER

0.5 ml of cream applied to skin site reactions as needed

Interventions

Bach's Rescue Remedy Cream

0.5 ml of cream applied to skin site reactions as needed

Intervention Type: OTHER

Placebo Cream

Placebo cream 0.5 ml two times a day as needed

Intervention Type: OTHER

Other Intervention Names

Rescue Cream; Base cream

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Charlotte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda A Moore, EdD, APRN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Charlotte

Locations

University of North Carolina at Charlotte

Charlotte, North Carolina, United States

Countries

United States

References

Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses. Mult Scler. 1998 Apr;4(2):70-3. doi: 10.1177/135245859800400205.

Reference Type: BACKGROUND

PMID: 9599336 (View on PubMed)

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. doi: 10.1002/j.2048-7940.2007.tb00179.x.

Reference Type: BACKGROUND

PMID: 18065143 (View on PubMed)

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

Reference Type: BACKGROUND

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. doi: 10.1097/01376517-200808000-00007.

Reference Type: BACKGROUND

PMID: 18727339 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 16673806 (View on PubMed)

Other Identifiers

TEVA 540837

Identifier Type: -

Identifier Source: org_study_id