Multiple SclerosisMSSkinNCT00972062
Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis
A study testing Bach's Rescue Remedy Cream in people with Multiple Sclerosis, run by University of North Carolina, Charlotte at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Bach's Rescue Remedy Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must demonstrate redness of skin site reactions
- Must demonstrate accurate injection technique prior to initiating the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Charlotte
Charlotte, North Carolina, 28223
About this study
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.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- Bach's Rescue Remedy Cream, Placebo Cream
- Keywords
- Subcutaneous injections, Skin abnormalities
- Medical subject headings
- Multiple Sclerosis, Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bach's Rescue Remedy CreamOther
Also called Rescue Cream
0.5 ml of cream applied to skin site reactions as needed
Placebo CreamOther
Also called Base cream
Placebo cream 0.5 ml two times a day as needed
| Study group | Role | What they receive |
|---|---|---|
| Placebo cream | Placebo comparator | Cream base used in compounding medications into cream media Receives: Other: Placebo Cream |
| Herbal Cream | Experimental | Herbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications Receives: Other: Bach's Rescue Remedy Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant decrease in time and size of redness based on daily measure of skin site reactions using herbal cream compared to placebo cream.
Measured: 7 days from each injection
Secondary outcomes (1)
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
- Investigators
- Linda A Moore, EdD, APRN, Principal investigator, University of North Carolina at Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972062
- Sponsor's protocol ID
- TEVA 540837
- Acronym
- MSSkin
- Status last verified
- Mar 2012
- First submitted
- 2 Sep 2009
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 9599336Moore 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.
PubMed 18065143Halper 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.
PubMed 18727339Samuel L, Lowenstein EJ. Recurrent injection site reactions from interferon beta 1-b. J Drugs Dermatol. 2006 Apr;5(4):366-7.
PubMed 16673806
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00972062
- Acronym / sponsor ID
- MSSkin / TEVA 540837
- Conditions
- Multiple Sclerosis
- Keywords
- Subcutaneous injections, Skin abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo cream | Placebo comparator | Other: Placebo CreamCream base used in compounding medications into cream media |
| Herbal Cream | Experimental | Other: Bach's Rescue Remedy CreamHerbal cream (Bach's Rescue Remedy Cream) applied to skin site reactions from MS medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must demonstrate redness of skin site reactions
- Must demonstrate accurate injection technique prior to initiating the study
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bach's Rescue Remedy CreamAlso: Rescue Cream0.5 ml of cream applied to skin site reactions as needed | Other | Herbal Cream |
| Placebo CreamAlso: Base creamPlacebo cream 0.5 ml two times a day as needed | Other | Placebo cream |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- Background: PubMed 9599336Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses. Mult Scler. 1998 Apr;4(2):70-3. doi: 10.1177/135245859800400205.
- Background: PubMed 18065143Moore 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.
- BackgroundHalper J, Harris C, Machler B. Manageing injection-site reactions in patients with MS. Multiple Sclerosis Counseling Points 1:1-10,2005
- Background: PubMed 18727339Jolly 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.
- Background: PubMed 16673806Samuel L, Lowenstein EJ. Recurrent injection site reactions from interferon beta 1-b. J Drugs Dermatol. 2006 Apr;5(4):366-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda A Moore, EdD, APRN principal investigator
University of North Carolina at Charlotte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bach's Rescue Remedy Cream in people with Multiple Sclerosis, run by University of North Carolina, Charlotte at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972062, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.