Doxepin hydrochloride 5% cream significantly reduces pruritus in burn patients in comparison with a placebo cream
ID
Bron
Verkorte titel
Aandoening
Itch, burns, jeuk, brandwonden
Ondersteuning
Association of Dutch Burn Centres
Zeestraat 27-29, 1941 AJ Beverwijk
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Doxepin hydrochloride 5% cream significantly reduces pruritus in burn patients in comparison with a placebo cream
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6233 |
| NTR-old | NTR6413 |
| Ander register | EudraCT number, METC-number : 2016-003862-25, NL59341.0.94.16 |