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

ISRCTN	ISRCTN18863931
DOI	https://doi.org/10.1186/ISRCTN18863931
Secondary identifying numbers	PSD502-PM-001

Submission date: 15/02/2007
Registration date: 20/04/2007
Last edited: 02/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Miss Sheryl Caswell
Scientific

Plethora Solutions
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom

Phone	+44 (0)207 269 8630
Email	sheryl.caswell@plethorasolutions.co.uk

Study information

Study design	Part 1: Uncontrolled open label study Part 2 Double-blind placebo controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Scientific title	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
Study hypothesis	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.
Ethics approval(s)	South West Multi-centre REC, 01/02/2006, ref: 06/MRE06/8
Condition	Management of pain from donor sites in burns subjects undergoing skin grafts.
Intervention	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. Part 1: Active PSD502 on one or both donor sites. Part 2: 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.
Intervention type	Other
Primary outcome measure	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 study start date	01/02/2006
Overall study end date	31/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	8 subjects in Part 1. 30 subjects in Part 2.
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
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	01/02/2006
Recruitment end date	31/10/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Plethora Solutions

London
WC2B 5NH
United Kingdom

Sponsor information

Plethora Solutions Ltd
Not defined

Lupus House
11-13 macklin Street
London
WC2B 5NH
London
WC2B 5NH
United Kingdom

Phone	+44 (0)207 269 8630
Email	mail@plethorasolutions.co.uk
Website	http://www.plethorasolutions.co.uk/index.php
"ROR"	https://ror.org/02y9vw172

Funders

Funder type

Industry

Plethora Solutions Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

02/02/2017: No publications found in PubMed, verifying study status with principal investigator.