Condition category
Skin and Connective Tissue Diseases
Date applied
15/02/2007
Date assigned
20/04/2007
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sheryl Caswell

ORCID ID

Contact details

Plethora Solutions
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
+44 (0)207 269 8630
sheryl.caswell@plethorasolutions.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSD502-PM-001

Study information

Scientific title

Acronym

Study hypothesis

The active ingredients of PSD502, lidocaine and prilocaine, are available in aqueous formulations such as creams and gels in the hydrochloride salt form, which facilitates their water solubility. Aqueous formulations, however, have poor residency, and while this factor is optimised by the use of creams and gels, they physically impede the movement of local anaesthetic down the concentration gradient and out of the gel, through the skin or mucous membrane surface. Therefore, these preparations have not been found to be successful with a drug that requires rapid delivery of relatively high concentrations of local anaesthetic. Aerosol preparations can employ the base form of local anaesthetic compounds, thereby facilitating drug penetration.

PSD502 is expected to provide a fast onset of anaesthesia when applied to non-keratinised skin, such as skin grafts, burns, leg ulcers and grazes, or to normal mucosa and to have beneficial effects in these patients in providing pain relief with an easy to use fast acting topical spray. Therefore, the present study has been designed with the objectives of 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

South West Multi-centre REC, approved on 01/02/2006, ref: 06/MRE06/8

Study design

This is a proof of principle study divided into Part 1, an uncontrolled open label study in 8 subjects, followed by Part 2, a double-blind placebo controlled study in not more than 30 subjects.

Primary study design

Interventional

Secondary study design

Other

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Phase

Phase II

Drug names

Primary outcome measures

To evaluate and compare the 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

01/02/2006

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

A subject will be considered suitable for the study if he or she fulfils all of the following 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

8 subjects in Part 1. 30 subjects in Part 2.

Participant exclusion criteria

A subject who fulfils any of the following criteria is excluded from the study:
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

United Kingdom

Trial participating centre

Plethora Solutions
London
WC2B 5NH
United Kingdom

Sponsor information

Organisation

Plethora Solutions Ltd

Sponsor details

Lupus House
11-13 macklin Street
London
WC2B 5NH
London
WC2B 5NH
United Kingdom
+44 (0)207 269 8630
mail@plethorasolutions.co.uk

Sponsor type

Not defined

Website

http://www.plethorasolutions.co.uk/index.php

Funders

Funder type

Industry

Funder name

Plethora Solutions Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Additional files

Editorial Notes