Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001039370p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
6/07/2026
Date registered
Help: Date registered
24/08/2026
Date last updated
Help: Date last updated
24/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the efficacy of multi-wavelength photobiomodulation for providing anaesthesia in intradermal injections
Scientific title
A randomised controlled trial evaluating the efficacy of multi-wavelength photobiomodulation for providing anaesthesia in intradermal injections
Additional trial identifiers [1] 317801 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Pain 342720 0
Condition category
Condition code
Anaesthesiology 338857 338857 0 0
Pain management
Skin 338858 338858 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What is the intervention
A multi-wavelength light-emitting diode (LED) device (700–1100nm, spanning visible and near-infrared light), applied to the skin to induce photobiomodulation-based analgesia prior to intradermal injection.

Who delivers it and their relevant expertise
The device is applied and the procedure conducted by the site investigators (dermatology medical clinicians) at Westmead Hospital Dermatology Outpatient Clinic that have been trained in the use of the device.

How it is delivered
Face-to-face, individual (one-on-one), in-person clinical procedure. The device is placed directly over a marked 1cm × 1cm site on the volar forearm. The participant will then receive an intradermal injection with a 30gauge needle with 0.1mL of 0.9% normal saline solution. The participant will then have a Telehealth phone call 1 week later to assess for any side effects.

How often and for how long
A single application per arm: the device is activated and held over the site for 60 seconds immediately before injection. Each participant receives this once on each forearm (one arm gets the intervention, the other the sham/control device) in a single study visit — i.e., 2 applications total (once per arm) within one session, of 60 seconds' duration each. No washout period is required as the previous device and injection will not have an effect on the other arm. The participant will then have a Telehealth phone call 1 week later to assess for any side effects.

Where it is delivered
Tertiary hospital setting: Dermatology Outpatient Clinic, Westmead Hospital, Sydney, Australia.

Adherence
As this is a single-session, investigator-administered procedure (not a self-administered or take-home intervention), adherence is ensured by direct investigator delivery and observation rather than participant reminders. Device application is standardised (60 seconds, over a marked and measured skin site) to ensure consistency across participants.
Intervention code [1] 334646 0
Treatment: Devices
Description of the comparator or control
What is the comparator
A sham light-emitting device (Device B) not delivering the active photobiomodulation treatment.

Who delivers it and their relevant expertise
Same site investigators who deliver the active intervention, at the same visit (within-subject/paired design — every participant receives both the active and sham device, one per arm).

How it is delivered
Face-to-face, individual, in-person — identical delivery method to the active intervention (applied to a marked 1cm × 1cm site on the contralateral forearm).

How often and for how long
Single 60-second application on the comparator arm, during the same visit as the active intervention (i.e., each participant serves as their own control, per the paired design).

Where it is delivered
Same setting: Dermatology Outpatient Clinic, Westmead Hospital, Sydney, Australia.

Adherence
As with the intervention, the comparator is investigator-delivered within a single supervised visit, so adherence is assured through direct administration rather than participant self-monitoring. Blinding is maintained by labelling devices "Device A" and "Device B" only, with participants unaware of which arm receives which device; investigators are not blinded since the active device requires calibration before each use.
Control group
Placebo

Outcomes
Primary outcome [1] 346070 0
Pain score using the Numeric Rating Scale (0–10) at the time of 30G hypodermic needle insertion
Timepoint [1] 346070 0
At time of needle insertion, during the single study visit
Primary outcome [2] 346071 0
Pain score using the NRS (0–10) at the time of injection of 0.1mL 0.9% sodium chloride into the intradermal plane.
Timepoint [2] 346071 0
Immediately following injection, during the single study visit.
Secondary outcome [1] 464493 0
Pain/discomfort associated with device application itself
Timepoint [1] 464493 0
At end of the 60-second device application, during the study visit.
Secondary outcome [2] 464494 0
Adverse events related to device application and injection site.
Timepoint [2] 464494 0
From the study visit up to 1 week post-application (assessed via telehealth follow-up).

Eligibility
Key inclusion criteria
Aged 18 years or older, able to provide consent
Able to use both forearms
Normal skin overlying both forearms
Able to verbalise and report pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Known hypersensitivity to 0.9% sodium chloride and/or hypodermic needles
Medical conditions that may be exacerbated by visible or near-infrared light devices
Medical conditions that may alter ability to detect/report pain and sensation at injection sites
Use of topical or systemic analgesia within 24 hours prior to the visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised — computer-generated sequence determines which forearm receives the active vs sham device
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2026
Actual
Date of last participant enrolment
Anticipated
4/10/2027
Actual
Date of last data collection
Anticipated
11/10/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29809 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 46155 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 322347 0
Commercial sector/Industry
Name [1] 322347 0
Dentroid
Country [1] 322347 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Dentroid
Address
Country
Australia
Secondary sponsor category [1] 325272 0
None
Name [1] 325272 0
Address [1] 325272 0
Country [1] 325272 0
Other collaborator category [1] 284022 0
Hospital
Name [1] 284022 0
Westmead Hospital
Address [1] 284022 0
Country [1] 284022 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 320848 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 320848 0
Ethics committee country [1] 320848 0
Australia
Date submitted for ethics approval [1] 320848 0
04/09/2026
Approval date [1] 320848 0
Ethics approval number [1] 320848 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151830 0
Prof Pablo Fernandez-Penas
Address 151830 0
Dermatology Department Westmead Hospital, Corner of Hawkesbury Road and Darcy Road, Westmead NSW 2145
Country 151830 0
Australia
Phone 151830 0
+61 88905686
Fax 151830 0
Email 151830 0
[email protected]
Contact person for public queries
Name 151831 0
Pablo Fernandez-Penas
Address 151831 0
Dermatology Department Westmead Hospital, Corner of Hawkesbury Road and Darcy Road, Westmead NSW 2145
Country 151831 0
Australia
Phone 151831 0
+61 88905686
Fax 151831 0
Email 151831 0
[email protected]
Contact person for scientific queries
Name 151832 0
Pablo Fernandez-Penas
Address 151832 0
Dermatology Department Westmead Hospital, Corner of Hawkesbury Road and Darcy Road, Westmead NSW 2145
Country 151832 0
Australia
Phone 151832 0
+61 88905686
Fax 151832 0
Email 151832 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.