Evaluation of Post Burn Rehabilitation Population for Itch Control

Pruritus Clinical Trial

Official title:

Evaluation of Provase in the Post Burn Rehabilitation Population for Itch Control and Moisturization Properties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782054
• Other study ID #: C-05-08573
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: October 27, 2008
• Start date: September 2006
• Est. completion date: April 2008

Study information

• Verified date: October 2008
• Source: Swiss-American Products, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post burn subject must be experiencing pruritus as defined by

• 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 will be excluded if pruritus is of nonburn etiology

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn Pruritus
• Burns
• Itching
• Pruritus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Villa Medica Rehabilitation Hospital	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Swiss-American Products, Inc	Hospital de readaptation Villa Medica, McGill University, Precision Consulting

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View Citation

Barnett L, Parnell LK. Contact dermatitis treated with new topical products: a case study. Ostomy Wound Manage. 2001 Sep;47(9):47-53. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yosipovitch G, Fleischer A. Itch associated with skin disease: advances in pathophysiology and emerging therapies. Am J Clin Dermatol. 2003;4(9):617-22. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary variables include antihistamine usage, skin condition, scar evaluation, and subject acceptance. Safety will be assessed via collection of adverse events.		4 weeks	Yes

External Links

•   McGill University Homepage
•   Villa Medica Rehabilitation Hospital Homepage