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Standard Treatment Or topical doxepin against Pruritus in burn patients.

Standard Treatment Or topical doxepin against Pruritus in burn patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25795
Enrollment
108
Registered
2013-03-06
Start date
2013-12-27
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pruritus, jeuk burns, brandwonden

Interventions

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.

Sponsors

Association of Dutch Burn Centres
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
To evaluate whether doxepin hydrochloride 5% cream is more effective in reducing pruritus in patients with burns than standard treatment.

Secondary

MeasureTime frame
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.

Contacts

Public ContactH.C. Kuipers

Association of Dutch Burn Centres Burn Center Martini Hospital Van Swietenplein 1

h.c.kuipers@mzh.nl+31 (0)50 5245565

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)