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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bach's Rescue Remedy Cream
Placebo Cream
Sponsored by
University of North Carolina, Charlotte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Subcutaneous injections, Skin abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Charlotte

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo cream

Herbal Cream

Arm Description

Cream base used in compounding medications into cream media

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

Outcomes

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.

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

Full Information

First Posted
September 2, 2009
Last Updated
March 6, 2012
Sponsor
University of North Carolina, Charlotte
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00972062
Brief Title
Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis
Acronym
MSSkin
Official Title
Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Charlotte
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: The herbal cream will significantly decrease time of redness based on daily measure of skin site reactions compared to placebo cream. The herbal cream will decrease discomfort of skin site reactions as measured by a visual analogue scale compared to the placebo cream. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Subcutaneous injections, Skin abnormalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo cream
Arm Type
Placebo Comparator
Arm Description
Cream base used in compounding medications into cream media
Arm Title
Herbal Cream
Arm Type
Experimental
Arm Description
Herbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications
Intervention Type
Other
Intervention Name(s)
Bach's Rescue Remedy Cream
Other Intervention Name(s)
Rescue Cream
Intervention Description
0.5 ml of cream applied to skin site reactions as needed
Intervention Type
Other
Intervention Name(s)
Placebo Cream
Other Intervention Name(s)
Base cream
Intervention Description
Placebo cream 0.5 ml two times a day as needed
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda A Moore, EdD, APRN
Organizational Affiliation
University of North Carolina at Charlotte
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28223
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9599336
Citation
Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses. Mult Scler. 1998 Apr;4(2):70-3. doi: 10.1177/135245859800400205.
Results Reference
background
PubMed Identifier
18065143
Citation
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.
Results Reference
background
Citation
Halper J, Harris C, Machler B. Manageing injection-site reactions in patients with MS. Multiple Sclerosis Counseling Points 1:1-10,2005
Results Reference
background
PubMed Identifier
18727339
Citation
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.
Results Reference
background
PubMed Identifier
16673806
Citation
Samuel L, Lowenstein EJ. Recurrent injection site reactions from interferon beta 1-b. J Drugs Dermatol. 2006 Apr;5(4):366-7.
Results Reference
background

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Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis

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