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Standard Treatment Or topical doxepin against Pruritus in burn patients.


- candidate number14467
- NTR NumberNTR3883
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2013
- Secondary IDsNL40807 / 2009-015090-12; ABR / EudraCT
- Public TitleStandard Treatment Or topical doxepin against Pruritus in burn patients.
- Scientific TitleStandard Treatment Or topical doxepin against Pruritus in burn patients.
- ACRONYMSTOP trial
- hypothesisDoxepin cream is more effective in reducing postburn pruritus compared with standard treatment.
- Healt Condition(s) or Problem(s) studiedBurns, Pruritus
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Patients with healed burns and itch;
2. Itch intensity as assessed by VAS score greater than or equal to 3;
3. Patients treated in one of the three Dutch burn centres;
4. Patients aged 18 years or older.
- Exclusion criteriaAn eligible subject who meets any of the following criteria will be excluded from participation in this study:
1. Inability to give informed consent by patient or legal representatives;
2. Inability to understand and fill in VAS scores and quality of life/pruritus assessment questionnaires, as judged by the treating physician;
3. Known pregnancy or breast-feeding;
4. (Active) cutaneous or systemic disease causing itch;
5. Any disease or condition which, according to the physician's judgement, is associated with adverse effects using doxepin.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-dec-2013
- planned closingdate1-jun-2014
- Target number of participants108
- InterventionsPatients will be randomised between:
1. Doxepin hydrochloride 5% cream, placebo tablets;
2. Placebo cream, clemastine 1 mg tablets.
Treatment will be given as long as the complaints persist.
- Primary outcomeTo evaluate whether doxepin hydrochloride 5% cream is more effective in reducing pruritus in patients with burns than standard treatment.
- Secondary outcomeTo evaluate whether patients treated with doxepin hydrochloride 5% cream compared to standard treatment:
1. Have a better quality of life;
2. Have less erythematous scars.
- TimepointsDuring the first two weeks patients will keep a diary. Furthermore patients will visit the out-patient clinic at randomisation (0 weeks), 2 weeks, 6 weeks and 12 weeks for additional assessments.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. H.C. Kuipers
- CONTACT for SCIENTIFIC QUERIESProf. R.S. Breederveld
- Sponsor/Initiator Association of Dutch Burn Centres
- Funding
(Source(s) of Monetary or Material Support)
Dutch Burns Foundation (Nederlandse Brandwonden Stichting)
- Publications1. Demling R, DeSanti L, Nelson R. Pruritus and burn wound. Wounds 2002;14:2A-7A.
2. Demling R, DeSanti L. Topical doxepin significantly decreases itching and erythema in the chronically pruritic burn scar. Wounds 2003;15(6):195-200.
- Brief summaryPruritus is a common problem in patients with healed burn wounds and causes severe morbidity. Standard treatment of pruritus consist of moisturizers, pressure garments and oral antihistamines. Doxepin hydrochloride 5% cream has potent H1 and H2 histamine receptor blocking properties and was found to have anti-pruritic properties in previous studies in patients with burns.
Our goal is to perform a randomised, double-blind study to evaluate the efficacy of doxepin hydrochloride 5% cream.
- Main changes (audit trail)
- RECORD6-mrt-2013 - 27-mrt-2014


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