Standard Topical Ointment or Doxepin against pruritus in burn patients

Standard Topical Ointment or Doxepin against pruritus in burn patients - 2-STOP trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45341

Enrollment

Registered

2017-02-22

Start date

2017-06-29

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Itch pruritus

Interventions

Crossover study: patients will receive both the Doxepin cream as well as the placebo cream. With which cream they will start will bed decided through randomisation. Three phases: 1. Two weeks cream

Burns

Doxepin

Itch

Pruritus

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * 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

Exclusion criteria

Exclusion criteria: * 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: o Contra-indications: * Hypersensitivity to any of its components o Precautions: * Glaucoma * A tendency to urinary retention * Sever liver disease * Mania * Sever heart disease (including cardiac arrhythmias) * Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
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. If the patient has more than one burn wound area (for example leg and arm) that itches, the area that causes the moist complaints will be designated as the study area. There can only be one study area.	—

Secondary

Measure	Time frame
The secondary study parameters include the determination of the MIC (Minimal Important Change) of the itch scores, the characteristics and impact of itch as measured by the BIQ (Burn Itch Questionnaire), and scar quality as measured by the POSAS (Patient and Observer Scar Assessment Scale). Other study parameters include: the use of hydrating cream, use of escape medication and use of pressure garments. Furthermore, we will register sex, age, medical history, cause of burn, location of burn wound, %TBSA burned, time to wound healing (will be estimated retrospectively), % burn wound area that itches, duration of itch, itch before inclusion and wound treatment (conservative or surgery).	—

Measure

Time frame

The secondary study parameters include the determination of the MIC (Minimal Important Change) of the itch scores, the characteristics and impact of itch as measured by the BIQ (Burn Itch Questionnaire), and scar quality as measured by the POSAS (Patient and Observer Scar Assessment Scale). Other study parameters include: the use of hydrating cream, use of escape medication and use of pressure garments. Furthermore, we will register sex, age, medical history, cause of burn, location of burn wound, %TBSA burned, time to wound healing (will be estimated retrospectively), % burn wound area that itches, duration of itch, itch before inclusion and wound treatment (conservative or surgery).

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)