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

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
University of North Carolina, Charlotte
ClinicalTrials.gov Identifier:
NCT00972062
First received: September 2, 2009
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Other: Bach's Rescue Remedy Cream
Other: Placebo Cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Charlotte:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Rescue 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972062

Locations
United States, North Carolina
University of North Carolina at Charlotte
Charlotte, North Carolina, United States, 28223
Sponsors and Collaborators
University of North Carolina, Charlotte
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Linda A Moore, EdD, APRN University of North Carolina at Charlotte
  More Information

Publications:
Responsible Party: University of North Carolina, Charlotte
ClinicalTrials.gov Identifier: NCT00972062     History of Changes
Other Study ID Numbers: TEVA 540837
Study First Received: September 2, 2009
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Charlotte:
Subcutaneous injections
Skin abnormalities

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014