Evaluation of Post Burn Rehabilitation Population for Itch Control

Swiss-American Products

Status and phase

Completed

Phase 4

Conditions

Itching

Burn Pruritus

Pruritus

Treatments

Other: Provase

Other: Control moisturizer

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00782054

C-05-08573

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No 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