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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ascending dose of 40 % Lidocaine Gel applied to patients with Postherpetic Neuralgia.
Scientific title
A Phase I/II Pilot Single Ascending Dose, Randomized, Double Blind, Placebo Controlled Study to Evaluate Two Topically Applied 40% Lidocaine Gel Formulations in Patients With Postherpetic Neuralgia (Protocol Number: LID-001)
Secondary ID [1] 1400 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster (shingle) 256778 0
Condition category
Condition code
Infection 256924 256924 0 0
Other infectious diseases

Study type
Description of intervention(s) / exposure
Ascending dose of 40% Lidocaine gel in two formulations.
Cohort 1a and 1b will receive one dose of 0.125 ml of gel applied by hand to the skin
Cohort 2a and 2b will recieve one dose of 0.250 mlof gel applied by hand.
Cohort 3a and 3b will recieve one dose of 0.500 ml of gel applied by hand.
Intervention code [1] 255984 0
Treatment: Drugs
Comparator / control treatment
Placebo gel. This Gel is similar to the active formulation however the active component is removed.
Control group

Primary outcome [1] 257800 0
Safety and Tolerabilty of two formulations of 40% Lidocaine gel at 0.125ml 0.250ml and 0.500 ml will be assesed on the basis of adverse events reported, vital signs and patient quesitonaire.
The potential adverse events expected in this study are: burning, swelling, redness, irratation, bruising of the skin. These site reaction are generally mild and resolve without treatment with in a few minutes to hours.
Timepoint [1] 257800 0
Patients will be continuously monitered while they are on the study.
Secondary outcome [1] 263214 0
To asses the affect of two formulations of 40% Lidocaine gel.
Timepoint [1] 263214 0
Patients will be asked to rate there pain intensity at 30 minutes, 1,2,4,6,8,12,16 and 24 hours post dose. The patients will do this by answering a qustionnaire.
Patients will also have a brush evoked pain assesment performed at 1,2,4,8,12,24 hours post dose. This assesment is performed by a doctor using a study specifc brush

Key inclusion criteria
Male or Female patients with a diagnosis of Herpes Zoster (shingles) with Posthepetic Neuralgia.
Minimum age
18 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Any significant unstable medical condition, allergic reaction or hypersensitivity to Lidocaine.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256487 0
Commercial sector/Industry
Name [1] 256487 0
Arcion Therapeutics, Inc
Address [1] 256487 0
2400 Boston Street, Suite 300 Baltimore, MD 21224
Country [1] 256487 0
United States of America
Primary sponsor type
Commercial sector/Industry
Nucleus Network
Level 5, AMREP Precinct
89 Commercail Road,
Melbourne, Victoria 3004
Secondary sponsor category [1] 255799 0
Name [1] 255799 0
Address [1] 255799 0
Country [1] 255799 0

Ethics approval
Ethics application status
Ethics committee name [1] 258537 0
The Alfred Research and Ethcis Unit
Ethics committee address [1] 258537 0
The Alfred Hospital, Commercial Road,23 Melbourne, Vicoria.
Ethics committee country [1] 258537 0
Date submitted for ethics approval [1] 258537 0
Approval date [1] 258537 0
Ethics approval number [1] 258537 0

Brief summary
Post Therpetic Neuralgia is the pain that persist after the shingles rash has gone. The purpose of this sutdy is to research the use of Lignocaine in treating this pain. There will be no long term benifits from particpating in this trial as the patients will only recieve one dose of study drug.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 30815 0
Address 30815 0
Country 30815 0
Phone 30815 0
Fax 30815 0
Email 30815 0
Contact person for public queries
Name 14062 0
Mary Franich
Address 14062 0
Centre for Clinical Studies.
5th Floor Burnet Tower, AMREP Precinct, 89 Commercail Road, Melbourne, Victoria, 3004
Country 14062 0
Phone 14062 0
1800 243 733
Fax 14062 0
61 3 90768911
Email 14062 0
Contact person for scientific queries
Name 4990 0
Associoate Prof Peter Hodsman
Address 4990 0
Centre for Clinical Studies.
5th Floor Burnet Tower, AMREP Precinct, 89 Commercail Road, Melbourne, Victoria, 3004
Country 4990 0
Phone 4990 0
61 3 90768900
Fax 4990 0
61 3 90768911
Email 4990 0

No information has been provided regarding IPD availability
Summary results
No Results