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Evaluation of Post Burn Rehabilitation Population for Itch Control

NCT00782054 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2008-10-29

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • McGill University

    collaborator OTHER

  • Hospital de readaptation Villa Medica

    collaborator UNKNOWN

  • Precision Consulting

    collaborator UNKNOWN

  • Swiss-American Products, Inc

    lead INDUSTRY

Principal Investigators

  • Leo LaSalle, M.D. · Villa Medica Rehabilitation Hospital

  • Bernadette Nedelec, BSc, OT, PhD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00782054 on ClinicalTrials.gov