Doxepin cream is more effective in reducing postburn pruritus compared with standard treatment.
ID
Bron
Verkorte titel
Aandoening
pruritus, jeuk
burns, brandwonden
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate whether doxepin hydrochloride 5% cream is more effective in reducing pruritus in patients with burns than standard treatment.
Achtergrond van het onderzoek
Pruritus 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.
Doel van het onderzoek
Doxepin cream is more effective in reducing postburn pruritus compared with standard treatment.
Onderzoeksopzet
During 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.
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
Burn Center Martini Hospital<br>
Van Swietenplein 1
H.C. Kuipers
Groningen 9728 NT
The Netherlands
+31 (0)50 5245565
h.c.kuipers@mzh.nl
Wetenschappelijk
Burn Center Martini Hospital<br>
Van Swietenplein 1
H.C. Kuipers
Groningen 9728 NT
The Netherlands
+31 (0)50 5245565
h.c.kuipers@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
An 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3720 |
| NTR-old | NTR3883 |
| CCMO | NL40807.094.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39365 |
Samenvatting resultaten
2. Demling R, DeSanti L. Topical doxepin significantly decreases itching and erythema in the chronically pruritic burn scar. Wounds 2003;15(6):195-200.