Evaluation of Post Burn Rehabilitation Population for Itch Control

Sponsor

Swiss-American Products, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00782054

Collaborator

McGill University (Other), Hospital de readaptation Villa Medica (Other), Precision Consulting (Other)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus Itching Burn Pruritus	Other: Provase Other: Control moisturizer	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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). [4 weeks]

Secondary Outcome Measures

Secondary variables include antihistamine usage, skin condition, scar evaluation, and subject acceptance. Safety will be assessed via collection of adverse events. [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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