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

September 2, 2009
March 6, 2012
June 2009
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00972062 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis
Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Other: Bach's Rescue Remedy Cream
    0.5 ml of cream applied to skin site reactions as needed
    Other Name: Rescue Cream
  • Other: Placebo Cream
    Placebo cream 0.5 ml two times a day as needed
    Other Name: Base cream
  • Placebo Comparator: Placebo cream
    Cream base used in compounding medications into cream media
    Intervention: Other: Placebo Cream
  • Experimental: Herbal Cream
    Herbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications
    Intervention: Other: Bach's Rescue Remedy Cream

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00972062
TEVA 540837
Yes
University of North Carolina, Charlotte
University of North Carolina, Charlotte
Teva Pharmaceutical Industries
Principal Investigator: Linda A Moore, EdD, APRN University of North Carolina at Charlotte
University of North Carolina, Charlotte
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP