No registrations found.
ID
Source
Brief title
Health condition
Itch, burns, jeuk, brandwonden
Sponsors and support
Association of Dutch Burn Centres
Zeestraat 27-29, 1941 AJ Beverwijk
Intervention
Outcome measures
Primary outcome
The 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 outcome
The 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).
Background summary
This 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.
Study objective
Doxepin hydrochloride 5% cream significantly reduces pruritus in burn patients in comparison with a placebo cream
Study design
Timepoint 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
Intervention
Patients 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.
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6233 |
| NTR-old | NTR6413 |
| Other | EudraCT number, METC-number : 2016-003862-25, NL59341.0.94.16 |