Acute minor burns
Conditions
Interventions
Product Name: PSD502
Product Code: PSD502
Pharmaceutical Form: Cutaneous spray, solution
INN or Proposed INN: Lidocaine
CAS Number: 137-58-6
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Plethora Solutions Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who fulfil all of the following criteria will be eligible for the study: 1. Male or female ASA class I/II (American Society of Anesthesiologists class I or II – Appendix IV of protocol) subjects with acute first degree burns on =5% body surface area that may or may not require de-roofing but do require cleaning and application of a dressing. 2. Subjects with single or multiple burns on only one part of the body, i.e. all burns at a single site of assessment 3. Subjects whose burns have cause predominantly superficial dermal injury and whose burns can be treated on an outpatient basis. 4. Subjects whose burn injury has occurred within 72 hours of the subject attending the clinic. 5. Subjects who have been given a standard dose of oral morphine (approximately 0.2-0.4 mg/kg) as routine management prior to treating the burn. 6. Subjects aged 18 - 75 years inclusive. 7. Subjects with normal clinical examination (except for burns). 8. Subjects who are able to understand and complete the VAPS form. 9. Subjects who are willing and able to provide written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who fulfil any of the following criteria will be excluded from the study: 1. Subjects whose burn injury has been previously debrided. 2. Subjects with facial burns or with burns sites on more than one part of the body. 3. Subjects who have received another investigational product within the previous 3 months. 4. Subjects with known hypersensitivity to amide-type local anaesthetics, or other known drug allergies. 5. Subjects who have taken analgesics, including paracetamol, within 2 hours of enrolment into the study, or an opiate within 4 hours prior to enrolment into the study (other than a standard dose of oral morphine on admission to the unit). 6. Subjects with a history of alcohol or drug abuse. 7. Female subjects who are pregnant or lactating. 8. Sexually active female subjects who are of child-bearing potential (<2 years post menopausal) and not using a reliable method of contraception (oral, injectable or implantable contraceptives, barrier methods of contraception, or surgically sterile). 9. Subjects who are currently taking, or have taken within the previous 2 weeks, any of the following medications: acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates (including glyceryl trinitrate), nitrites, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, or sulfonamides. 10. Known liver disease, known renal disease or heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of PSD502 compared with placebo in relieving pain from acute minor burns, as assessed by visual analogue pain scale (VAPS), during immediate burns management.;Secondary Objective: To evaluate the safety and tolerability of PSD502.;Primary end point(s): Efficacy: Pain will be assessed by subjects using a 100 mm VAPS. The primary efficacy variable is the retrospective VAPS to assess pain felt during the procedure by PSD502 and placebo-treated subjects. The secondary efficacy variable is the change from pre-dose in the mean VAPS score from 0.25 to 2 hours post-treatment to assess pain felt at the burn site for PSD502 and placebo-treated subjects. Safety: Adverse events and any serious adverse events will be recorded throughout the study. Routine safety monitoring will include vital signs (heart rate, blood pressure, respiratory rate) at screening (pre-dose), 0.5 and 2 hours after dosing. | — |
Countries
United Kingdom
Outcome results
None listed