Standard Treatment Or topical doxepin against Pruritusin burn patients

Conditions: Pruritus in patients with burns
MedDRA version: 16.0Level: LLTClassification code 10006799Term: Burns NOSSystem Organ Class: 100000004863
MedDRA version: 16.0Level: LLTClassification code 10037090Term: Pruritus cutaneousSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2009-015090-12-NL

Lead Sponsor: Association of Dutch Burn Centres

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Patients with healed burns and itch. Patients are divided into four groups i.e.
1) patients with partial thickness wounds, not exceeding 4 months postburn
2) patients with full thickness wounds, not exceeding 4 months postburn
3) patients with partial thickness wounds between 4 months postburn and 3 years postburn
4) patients with full thickness wounds between 4 months postburn and 3 years postburn
• Itch intensity as assessed by VAS score greater than or equal to 3
• Patients treated in one of the three Dutch burn centres
• Patients aged 18 years or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 103
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Inability to give informed consent by patient or legal representatives
- Inability to understand and fill in VAS scores and quality of life/pruritus assessment questionnaires, as judged by the treating physician
- (Active) cutaneous or systemic disease causing itch
- Any disease or condition which, according to the physician's judgement, is associated with adverse effects using doxepin, that is:
Contra-indications Tavegil
- hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients
- porphyria
Precautions Tavegil:
- fructose intolerance
- narrow-angle glaucoma
- stenosing peptic ulcer
- pyloroduodenal obstruction
- prostatic hypertrophy with urinary retention and bladder neck obstruction
- galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- pregnancy and lactation
Contra-indications Xepin:
- hypersensitivity to any of its components.
Precautions Xepin
- glaucoma
- a tendency to urinary retention
- severe liver disease
- mania
- severe heart disease (including cardiac arrythmias)
- pregnancy and lactation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether doxepin hydrochloride 5% cream is more effective in reducing pruritus in patients with burns than standard treatment.;Secondary Objective: To evaluate whether patients treated with doxepin hydrochloride 5% cream compared to standard treatment:<br>- have a better quality of life<br>- have less erythematous scars;Primary end point(s): The main study parameters are change in mean pruritus intensity; VAS scores from baseline during 12 weeks of treatment;Timepoint(s) of evaluation of this end point: VAS pruritus: 0 weeks (inclusion), day 1-13 (daily), 2 weeks, 6 weeks, 12 weeks (end of study)

Secondary Outcome Measures