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van CCT (UK)

van CCT (UK)

Behandeling van jeukklachten bij brandwondpatiënten met doxepine crème

- candidate number26815
- NTR NumberNTR6413
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mrt-2017
- Secondary IDs2016-003862-25, NL59341.0.94.16 EudraCT number, METC-number
- Public TitleBehandeling van jeukklachten bij brandwondpatiënten met doxepine crème
- Scientific TitleStandard Topical Ointment or doxepin against Pruritus in burn patients
- hypothesisDoxepin hydrochloride 5% cream significantly reduces pruritus in burn patients in comparison with a placebo cream
- Healt Condition(s) or Problem(s) studiedItch, Burns
- Inclusion criteria- Age ≥ 18 years
- Healed burns
- Itch with an intensity ≥ 3 as determined by the VAS score for itch at time of the enrolment
- Treatment in one of the three Dutch burn centres
- Total area that itches must not exceed >10% TBSA
- Exclusion criteria- Unable to give informed consent
- Unable to understand and fill in VAS scores and questionnaires (as determined by the treating burn physician)
- Cutaneous or systemic disease causing itch
- Any diseases or condition that is associated with adverse effects using doxepin, that is: Hypersensitivity to any of its components, Glaucoma, A tendency to urinary retention, Sever liver disease, Mania, Sever heart disease (including cardiac arrhythmias), Pregnancy and lactation
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate1-mei-2018
- Target number of participants27
- InterventionsPatients will be randomized to start with either the doxepin cream or the placebo cream. Patients will be required to use the cream at least once daily for two consecutive weeks. This is followed by a one week wash-out period after which they continue with the other cream at least once daily for another two weeks.
- Primary outcomeThe main study parameter is the change in pruritus intensity as measured by the Visual Analogue Scale (VAS), with a decrease of ≥2 point being defined as clinically significant.
- Secondary outcomeThe secondary study parameters include the determination of the MIC of the itch scores, the characteristics and impact of itch as measured by the BIQ, and scar quality as measured by the POSAS.
Other study parameters include: the use of hydrating cream, use of escape medication and use of pressure garments. Furthermore, we will register sex, age, medical history, cause of burn, location of burn wound, %TBSA burned, time to wound healing (will be estimated retrospectively), % burn wound area that itches, duration of itch, itch before inclusion and wound treatment (conservative or surgery).
- TimepointsTimepoint 0: baseline data, burns itch questionnaire and POSAS.
Daily 1-14: VAS (itch score), side effects, use of other medication, use of escape moisturizer, use of pressure garments.
Day 14: burns itch questionnaire
Daily 22-35: VAS (itch score), side effects, use of other medication, use of escape moisturizer, use of pressure garments.
At 5-6 weeks: burns itch questionnaire
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator Association of Dutch Burn Centres
- Funding
(Source(s) of Monetary or Material Support)
Dutch Burns Foundation (Nederlandse Brandwonden Stichting)
- Publications
- Brief summaryThis is a multicentre, double-blind, randomized, placebo-controlled cross-over trial to investigate whether the use of doxepin cream versus a placebo cream significantly reduces itch by comparing itch scores in patients with healed burns.
- Main changes (audit trail)
- RECORD3-mrt-2017 - 13-mei-2018

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