No registrations found.
ID
Source
Brief title
Health condition
pruritus, jeuk
burns, brandwonden
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate whether doxepin hydrochloride 5% cream is more effective in reducing pruritus in patients with burns than standard treatment.
Secondary outcome
To 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.
Background summary
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.
Study objective
Doxepin cream is more effective in reducing postburn pruritus compared with standard treatment.
Study design
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.
Intervention
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.
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
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
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3720 |
| NTR-old | NTR3883 |
| CCMO | NL40807.094.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39365 |
Summary results
2. Demling R, DeSanti L. Topical doxepin significantly decreases itching and erythema in the chronically pruritic burn scar. Wounds 2003;15(6):195-200.