Evaluation of Post Burn Rehabilitation Population for Itch Control
NCT ID: NCT00782054
Last Updated: 2008-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
23 participants
INTERVENTIONAL
2006-09-30
2008-04-30
Brief Summary
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Swiss-American Products, Inc, has developed a new skin moisturizer containing a blend of endopeptidase enzymes. These products have resolved itching in other types of skin disease such as dermatitis. The hypothesis that itching can be reduced through the use of these endopeptidase enzyme containing products in the post burn population will be tested.
Detailed Description
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Swiss-American Products, Inc, has developed new non-prescription skin products containing a blend of endopeptidase enzymes in a moisturizer base to aid the body during recovery from injury and inflammation. In Stage II and III pressure ulcers, an amorphous hydrogel containing the enzymes was observed to help resolve inflammation and enhance healing. Anecdotal reports indicate a fast release cream with the enzymes, applied to insect stings and bites on intact skin resolved the itching and reduced, sometimes even preventing, edema. In a case study of chronic persistent contact dermatitis, one product was successfully used for immediate relief of pruritus and the slow release version was used for relief at night. Several centers have independently reported the resolution of pruritus associated with cellulitis in subjects with chronic wounds.
The hypothesis that itching can be reduced through the use of endopeptidase enzyme containing product in the post burn population will be tested. The use of the product has not been previously evaluated in burn subjects with pruritus. The primary objective of the preliminarily study would be to detect reduction of post burn itching through the use of the endopeptidase enzyme containing product.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active
moisturizer with endopeptidases
Provase
NDC:60230-8573-0 Over the counter (OTC) moisturizer containing 2% dimethicone and a blend of endopeptidases. Use topically to affected area every 8 hours.
Placebo
moisturizer without endopeptidases
Control moisturizer
Over the counter (OTC) moisturizer containing 2% dimethicone. Use topically to affected area every 8 hours. Does NOT contain endopeptidases. Placebo intervention is identical to active intervention EXCEPT it does not contain endopeptidases.
Interventions
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Provase
NDC:60230-8573-0 Over the counter (OTC) moisturizer containing 2% dimethicone and a blend of endopeptidases. Use topically to affected area every 8 hours.
Control moisturizer
Over the counter (OTC) moisturizer containing 2% dimethicone. Use topically to affected area every 8 hours. Does NOT contain endopeptidases. Placebo intervention is identical to active intervention EXCEPT it does not contain endopeptidases.
Eligibility Criteria
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Inclusion Criteria
* at least three episodes of itch during the past week AND
* itching occurs at least twice during the episode day AND
* itching lasts for more than 5 minutes and is bothersome
* TBSA of burn is between 10 and 70%
* Currently performing rehabilitation at Villa Medica Rehabilitation Hospital
* Subject available for 4 weeks
* Test area has complete epithelialization
* Subject is willing to complete daily diary
* Subject is male or female and over 18 years of age
Exclusion Criteria
* Subject requires topical steroids, topical antihistamines, or other topical medication and such medication cannot be discontinued
* Subject with known sensitivity to the enzyme papain or to the papaya fruit
* Subject requires immunosuppressives such as systemic steroid therapy, cancer chemotherapeutic agents
* Subject presently requires morphine for pain relief
* Subject is a known alcohol or drug abuser
* Subject is unable to communicate pain and itch scores or medication used
18 Years
ALL
No
Sponsors
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McGill University
OTHER
Hospital de readaptation Villa Medica
UNKNOWN
Precision Consulting
UNKNOWN
Swiss-American Products, Inc
INDUSTRY
Responsible Party
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Hospital de readaptation Villa Medica
Principal Investigators
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Leo LaSalle, M.D.
Role: PRINCIPAL_INVESTIGATOR
Villa Medica Rehabilitation Hospital
Bernadette Nedelec, BSc, OT, PhD
Role: STUDY_CHAIR
McGill University
Locations
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Villa Medica Rehabilitation Hospital
Montreal, Quebec, Canada
Countries
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References
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Field T, Peck M, Scd, Hernandez-Reif M, Krugman S, Burman I, Ozment-Schenck L. Postburn itching, pain, and psychological symptoms are reduced with massage therapy. J Burn Care Rehabil. 2000 May-Jun;21(3):189-93. doi: 10.1067/mbc.2000.105087.
Dunnick CA, Gibran NS, Heimbach DM. Substance P has a role in neurogenic mediation of human burn wound healing. J Burn Care Rehabil. 1996 Sep-Oct;17(5):390-6. doi: 10.1097/00004630-199609000-00004.
Yosipovitch G, Fleischer A. Itch associated with skin disease: advances in pathophysiology and emerging therapies. Am J Clin Dermatol. 2003;4(9):617-22. doi: 10.2165/00128071-200304090-00004.
Matheson JD, Clayton J, Muller MJ. The reduction of itch during burn wound healing. J Burn Care Rehabil. 2001 Jan-Feb;22(1):76-81; discussion 75. doi: 10.1097/00004630-200101000-00017.
Baker RA, Zeller RA, Klein RL, Thornton RJ, Shuber JH, Marshall RE, Leibfarth AG, Latko JA. Burn wound itch control using H1 and H2 antagonists. J Burn Care Rehabil. 2001 Jul-Aug;22(4):263-8. doi: 10.1097/00004630-200107000-00003.
Parnell LK, Ciufi B, Gokoo CF. Preliminary use of a hydrogel containing enzymes in the treatment of stage II and stage III pressure ulcers. Ostomy Wound Manage. 2005 Aug;51(8):50-60.
Barnett L, Parnell LK. Contact dermatitis treated with new topical products: a case study. Ostomy Wound Manage. 2001 Sep;47(9):47-53.
Yosipovitch G, Goon AT, Wee J, Chan YH, Zucker I, Goh CL. Itch characteristics in Chinese patients with atopic dermatitis using a new questionnaire for the assessment of pruritus. Int J Dermatol. 2002 Apr;41(4):212-6. doi: 10.1046/j.1365-4362.2002.01460.x.
Yosipovitch G, Zucker I, Boner G, Gafter U, Shapira Y, David M. A questionnaire for the assessment of pruritus: validation in uremic patients. Acta Derm Venereol. 2001 May;81(2):108-11. doi: 10.1080/00015550152384236.
Nedelec B, Shankowsky HA, Tredget EE. Rating the resolving hypertrophic scar: comparison of the Vancouver Scar Scale and scar volume. J Burn Care Rehabil. 2000 May-Jun;21(3):205-12. doi: 10.1067/mbc.2000.104750.
Related Links
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McGill University Homepage
Villa Medica Rehabilitation Hospital Homepage
Other Identifiers
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C-05-08573
Identifier Type: -
Identifier Source: org_study_id