Evaluation of Post Burn Rehabilitation Population for Itch Control

NCT00782054 | Completed Phase 4 DMC

• 1 other identifier: C-05-08573
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pruritus; Itching; Burn Pruritus

Keywords

pruritus; itch; burn; endopeptidase; moisturizer; randomized controlled

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Secondary variables include antihistamine usage, skin condition, scar evaluation, and subject acceptance. Safety will be assessed via collection of adverse events.

  4 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

moisturizer with endopeptidases

Other: Provase

Placebo

PLACEBO COMPARATOR

moisturizer without endopeptidases

Other: Control moisturizer

Interventions

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.

Active

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss-American Products, Inc: lead
• McGill University: collaborator
• Hospital de readaptation Villa Medica: collaborator
• Precision Consulting: collaborator

Study Sites (1)

Villa Medica Rehabilitation Hospital

Montreal, Quebec, H2W 1T8, Canada

Location

Related Publications (10)

• 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.

  PMID: 10850898 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.

  PMID: 8889861 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.

  PMID: 12926980 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.

  PMID: 11227690 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.

  PMID: 11482684 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.

  PMID: 16234576 BACKGROUND

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

  PMID: 11889744 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.

  PMID: 12031029 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.

  PMID: 11501646 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.

  PMID: 10850901 BACKGROUND

Related Links

• McGill University Homepage
• Villa Medica Rehabilitation Hospital Homepage

MeSH Terms

Conditions

Pruritus; Burns

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Leo LaSalle, M.D.

  Villa Medica Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Bernadette Nedelec, BSc, OT, PhD

  McGill University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 29, 2008
• Study Start: September 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 29, 2008

Record last verified: 2008-10

Locations

CA (1)