Miss Sheryl Caswell
11-13 Macklin Street
+44 (0)207 269 8630
Phase II, multi-centre, randomised, two-part pilot study (Part 1 open, uncontrolled; Part 2 double-blind, placebo controlled) to determine the efficacy, safety, tolerability and preliminary pharmacokinetics of PSD502 in the management of pain from donor sites in burns subjects undergoing skin grafts
The aim of this study is to determine determining the efficacy of PSD502 in relieving the pain of skin graft donor sites in patients with severe burns, and the safety and tolerability of the preparation when applied to exposed dermal tissue.
South West Multi-centre REC, 01/02/2006, ref: 06/MRE06/8
Part 1: Uncontrolled open label study
Part 2 Double-blind placebo controlled study
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Management of pain from donor sites in burns subjects undergoing skin grafts.
PSD502 is a metered dose aerosol spray that delivers a eutectic mixture of lidocaine and prilocaine. The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant.
Active PSD502 on one or both donor sites.
1. PSD502 and matching placebo on those subjects with paired donor sites (randomized and double-blind).
2. PSD502 or matching placebo on those subjects with one donor site.
Primary outcome measures
Efficacy of PSD502 with placebo in relieving pain, as assessed by visual analogue pain scale (VAPS), from skin graft donor sites.
Secondary outcome measures
1. To evaluate the safety and tolerability of PSD502 applied to skin graft donor sites
2. To characterise the preliminary pharmacokinetics of PSD502
3. To evaluate and compare the effect of PSD502 with placebo on morphine requirements
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Male or female ASA class I/II (American Society of Anesthesiologists class I or II) with burns that require skin grafts
2. Scheduled to have skin grafted from one or two donor sites.
3. Aged 18 - 75 years inclusive
4. Normal clinical examination (except for burns)
5. Able to understand and complete the VAPS form
6. Willing and able to provide written informed consent
Target number of participants
8 subjects in Part 1. 30 subjects in Part 2.
Participant exclusion criteria
1. Skin grafted from three or more donor sites
2. Receipt of another investigational product within 3 months prior to screening
3. Known hypersensitivity to amide-type local anaesthetics, or other known drug allergies
4. Requirement for amide local anaesthetics pre- or intra-operatively. Should a subject receive amide local anaesthetics pre- or intra-operatively, they must be withdrawn
5. Clinically relevant abnormality on ECG, in the opinion of the investigator, such as prolonged QTc
6. History of alcohol or drug abuse
7. Clinically significant abnormal blood biochemistry or haematology, in the opinion of the investigator
8. History of psychiatric illness, from vulnerable groups, or have learning difficulties.
9. Female subjects who are pregnant or lactating
10. Sexually active females 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)
11. Currently taking, or have taken within the 2 weeks prior to screening, 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
12. Have taken paracetamol within 2 hours of receiving study treatment
13. Known liver disease, known renal disease or heart failure
Additional Exclusion Criterion for Part 2:
14. Size of donor site(s) exceeds the area that can be covered by the maximum dose
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Plethora Solutions Limited (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting