Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis (MSSkin)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Placebo Cream; Other: Bach's Rescue Remedy Cream

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28223
      • University of North Carolina at Charlotte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo cream; Cream base used in compounding medications into cream media	Other: Placebo Cream; Placebo cream 0.5 ml two times a day as needed; Other Names: Base cream
Experimental: Herbal Cream; Herbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications	Other: Bach's Rescue Remedy Cream; 0.5 ml of cream applied to skin site reactions as needed; Other Names: Rescue Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Charlotte
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Principal Investigator: Linda A Moore, EdD, APRN, University of North Carolina at Charlotte

Publications and helpful links

General Publications

• Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses. Mult Scler. 1998 Apr;4(2):70-3. doi: 10.1177/135245859800400205.
• 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.
• 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. doi: 10.1097/01376517-200808000-00007.
• Samuel L, Lowenstein EJ. Recurrent injection site reactions from interferon beta 1-b. J Drugs Dermatol. 2006 Apr;5(4):366-7.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: September 3, 2009
• First Posted (Estimate): September 4, 2009

Study Record Updates

• Last Update Posted (Estimate): March 7, 2012
• Last Update Submitted That Met QC Criteria: March 6, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Subcutaneous injections; Skin abnormalities
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Drug-Related Side Effects and Adverse Reactions; Extravasation of Diagnostic and Therapeutic Materials; Multiple Sclerosis; Sclerosis; Injection Site Reaction
• Other Study ID Numbers: TEVA 540837