PruritusPhase 4NCT00782054
Evaluation of Post Burn Rehabilitation Population for Itch Control
A Phase 4 study testing Provase in people with Pruritus and Itching, run by Swiss-American Products, Inc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Itching, Burn Pruritus
- What is being tested?
- Provase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Provase in the Post Burn Rehabilitation Population for Itch Control and Moisturization Properties
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.
Read the 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.
- Conditions
- Pruritus, Itching, Burn Pruritus
- Being tested
- Provase, Control moisturizer
- Keywords
- pruritus, itch, burn, endopeptidase, moisturizer, randomized controlled
- Medical subject headings
- Pruritus, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProvaseOther
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.
Control moisturizerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | moisturizer with endopeptidases Receives: Other: Provase |
| Placebo | Placebo comparator | moisturizer without endopeptidases Receives: Other: Control moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss-American Products, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University, Hospital de readaptation Villa Medica, Precision Consulting
- Investigators
- Leo LaSalle, M.D., Principal investigator, Villa Medica Rehabilitation HospitalBernadette Nedelec, BSc, OT, PhD, Study chair, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782054
- Sponsor's protocol ID
- C-05-08573
- Status last verified
- Oct 2008
- First submitted
- 27 Oct 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10850898Dunnick 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.
PubMed 8889861Yosipovitch 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.
PubMed 12926980Matheson 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.
PubMed 11227690Baker 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.
PubMed 11482684Parnell 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.
PubMed 16234576Barnett L, Parnell LK. Contact dermatitis treated with new topical products: a case study. Ostomy Wound Manage. 2001 Sep;47(9):47-53.
PubMed 11889744Yosipovitch 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.
PubMed 12031029Yosipovitch 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.
PubMed 11501646Nedelec 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.
PubMed 10850901
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Provase in the Post Burn Rehabilitation Population for Itch Control and Moisturization Properties
- ClinicalTrials.gov ID
- NCT00782054
- Acronym / sponsor ID
- C-05-08573
- Conditions
- Pruritus, Itching, Burn Pruritus
- Keywords
- pruritus, itch, burn, endopeptidase, moisturizer, randomized controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Swiss-American Products, IncIndustry (pharma, biotech, devices)
- Collaborators
- McGill University, Hospital de readaptation Villa Medica, Precision Consulting
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Other: Provasemoisturizer with endopeptidases |
| Placebo | Placebo comparator | Other: Control moisturizermoisturizer without endopeptidases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProvaseNDC: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 | Active |
| Control moisturizerOver 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. | Other | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2008.
- Background: PubMed 10850898Field 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.
- Background: PubMed 8889861Dunnick 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.
- Background: PubMed 12926980Yosipovitch 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.
- Background: PubMed 11227690Matheson 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.
- Background: PubMed 11482684Baker 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.
- Background: PubMed 16234576Parnell 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.
- Background: PubMed 11889744Barnett L, Parnell LK. Contact dermatitis treated with new topical products: a case study. Ostomy Wound Manage. 2001 Sep;47(9):47-53.
- Background: PubMed 12031029Yosipovitch 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.
- Background: PubMed 11501646Yosipovitch 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.
- Background: PubMed 10850901Nedelec 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.
- McGill University HomepageLink provided by the sponsor.
- Villa Medica Rehabilitation Hospital HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leo LaSalle, M.D. principal investigator
Villa Medica Rehabilitation Hospital
Bernadette Nedelec, BSc, OT, PhD study chair
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Provase in people with Pruritus and Itching, run by Swiss-American Products, Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00782054, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2008.