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

March 6, 2012 updated by: University of North Carolina, Charlotte
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 7 days from each injection
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
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEVA 540837

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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