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| Name | Class |
|---|---|
| McGill University | OTHER |
| Hospital de readaptation Villa Medica | UNKNOWN |
| Precision Consulting | UNKNOWN |
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Severe itching following burn injury is a common complication. As many as 87% of burn patients report severe itching. The intense itching can increase anxiety and can interfere with sleep and normal activities of daily living thus affecting quality of life. Often the itching will become so intense patients will scratch or rub the skin until an open wound develops. Current treatment for itching includes antihistamines, steroids. and/or moisturizers, but too often, the patient does not receive relief, even from drugs, and suffers undesirable side effects.
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.
The mechanism of pruritus is poorly understood, but much stems from the inflammatory process during wound healing. Damaged nerve endings, substance P, mast cells releasing histamines, and presence of inflammatory prostaglandins can induce neuropathic and peripheral pruritoceptive itching. Absence of oil glands leading to dry skin and itching further aggravate the itching.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | moisturizer with endopeptidases |
|
| Placebo | Placebo Comparator | moisturizer without endopeptidases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provase | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary variables will be the responses on the Yosipovitch and Matheson instruments for each sensation/affect of itch category (tickling, stinging, crawling, stabbing, pinching, burning) and on severity (none, mild, moderate, and severe). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary variables include antihistamine usage, skin condition, scar evaluation, and subject acceptance. Safety will be assessed via collection of adverse events. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leo LaSalle, M.D. | Villa Medica Rehabilitation Hospital | Principal Investigator |
| Bernadette Nedelec, BSc, OT, PhD | McGill University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Villa Medica Rehabilitation Hospital | Montreal | Quebec | H2W 1T8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10850898 | Background | 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. | |
| 8889861 | Background | 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. |
| Label | URL |
|---|---|
| McGill University Homepage | View source |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| D002056 | Burns |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Control moisturizer | Other | 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. |
|
| 12926980 | Background | 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. |
| 11227690 | Background | 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. |
| 11482684 | Background | 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. |
| 16234576 | Background | 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. |
| 11889744 | Background | Barnett L, Parnell LK. Contact dermatitis treated with new topical products: a case study. Ostomy Wound Manage. 2001 Sep;47(9):47-53. |
| 12031029 | Background | 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. |
| 11501646 | Background | 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. |
| 10850901 | Background | 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. |
| Villa Medica Rehabilitation Hospital Homepage | View source |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |