Evaluation of Post Burn Rehabilitation Population for Itch Control

This study has been completed.
Sponsor:
Collaborators:
McGill University
Hospital de readaptation Villa Medica
Precision Consulting
Information provided by:
Swiss-American Products, Inc
ClinicalTrials.gov Identifier:
NCT00782054
First received: October 27, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pruritus
Itching
Burn Pruritus
Other: Provase
Other: Control moisturizer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Provase in the Post Burn Rehabilitation Population for Itch Control and Moisturization Properties

Resource links provided by NLM:


Further study details as provided by Swiss-American Products, Inc:

Primary Outcome Measures:
  • 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). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary variables include antihistamine usage, skin condition, scar evaluation, and subject acceptance. Safety will be assessed via collection of adverse events. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active
moisturizer with endopeptidases
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.
Placebo Comparator: Placebo
moisturizer without endopeptidases
Other: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782054

Locations
Canada, Quebec
Villa Medica Rehabilitation Hospital
Montreal, Quebec, Canada, H2W 1T8
Sponsors and Collaborators
Swiss-American Products, Inc
McGill University
Hospital de readaptation Villa Medica
Precision Consulting
Investigators
Principal Investigator: Leo LaSalle, M.D. Villa Medica Rehabilitation Hospital
Study Chair: Bernadette Nedelec, BSc, OT, PhD McGill University
  More Information

Additional Information:
Publications:

Responsible Party: Leo LaSalle, Hospital de readaptation Villa Medica
ClinicalTrials.gov Identifier: NCT00782054     History of Changes
Other Study ID Numbers: C-05-08573
Study First Received: October 27, 2008
Last Updated: October 27, 2008
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Swiss-American Products, Inc:
pruritus
itch
burn
endopeptidase
moisturizer
randomized controlled

Additional relevant MeSH terms:
Burns
Pruritus
Wounds and Injuries
Skin Diseases
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014