NCT00972062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

September 2, 2009

Last Update Submit

March 6, 2012

Conditions

Multiple Sclerosis

Keywords

Subcutaneous injectionsSkin abnormalities

Outcome Measures

Primary Outcomes (1)

  • Significant decrease in time and size of redness based on daily measure of skin site reactions using herbal cream compared to placebo cream.

    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

    2 weeks

Study Arms (2)

Placebo cream

PLACEBO COMPARATOR

Cream base used in compounding medications into cream media

Other: Placebo Cream

Herbal Cream

EXPERIMENTAL

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

Other: Bach's Rescue Remedy Cream

Interventions

Bach's Rescue Remedy CreamOTHER

0.5 ml of cream applied to skin site reactions as needed

Also known as: Rescue Cream
Herbal Cream
Placebo CreamOTHER

Placebo cream 0.5 ml two times a day as needed

Also known as: Base cream
Placebo cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must demonstrate redness of skin site reactions
  • Must demonstrate accurate injection technique prior to initiating the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Charlotte

Charlotte, North Carolina, 28223, United States

Location

Related Publications (5)

  • Gaines AR, Varricchio F. Interferon beta-1b injection site reactions and necroses. Mult Scler. 1998 Apr;4(2):70-3. doi: 10.1177/135245859800400205.

    PMID: 9599336BACKGROUND

  • 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.

    PMID: 18065143BACKGROUND

  • Halper J, Harris C, Machler B. Manageing injection-site reactions in patients with MS. Multiple Sclerosis Counseling Points 1:1-10,2005

    BACKGROUND

  • 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.

    PMID: 18727339BACKGROUND

  • Samuel L, Lowenstein EJ. Recurrent injection site reactions from interferon beta 1-b. J Drugs Dermatol. 2006 Apr;5(4):366-7.

    PMID: 16673806BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisSkin Abnormalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Linda A Moore, EdD, APRN

    University of North Carolina at Charlotte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 4, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

US(1)