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KeloidPhase 2NCT06138964

Comparing the Effect of siSPARC Microneedle Patch Versus siSPARC+siLR4A Microneedle Patch on Post-surgical Scars

A Phase 2 study testing siSPARC + siLR4A microneedle patches and siSPARC microneedle patch in people with Keloid and Wound Heal, run by National Skin Centre at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized, double-blind controlled study aims to compare the effect on appearance of post- surgical scars between daily application of siSPARC microneedle patch versus siSPARC + siLR4A microneedle patches. These are patches comprising short microneedles embedded with hydrolysed RNA (siRNAs). Read more about this study

Who is it for?
Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Keloid, Wound Heal, Wound
What is being tested?
siSPARC + siLR4A microneedle patches and siSPARC microneedle patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSingapore
Study dates
14 Nov 2023to 14 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult
  • Age 21-75
  • 2 weeks (+/- 7 days) after surgical operation with incision into the dermis
  • Post-stitch removal when stitches were applied
  • Wound closure/union achieved

Who cannot join

  • Pregnant or lactating participant
  • Participants with wound infection
  • Participants assessed to be uncooperative or unable to self-administer the interventions
  • Participants with known contact allergy to ingredients in the patch formulation (comprising hyaluronic acid, siRNA and glue) and/or isopropyl alcohol
  • Participants who are unable to personally consent (for e.g., cognitively impaired)

Trial locations and contacts

1 site in 1 country.

Hong Liang Tey contact

6350 6666

teyhongliang@ntu.edu.sg

Delwyn Lim contact

6350 6666

delwynlim@Outlook.com

Singapore1 site, 1 recruiting

  • National Skin Centre

    Singapore, 308205

    General National Skin Centre Contact, (65) 6253 4455

    Recruiting

Other trials in Singapore

About this study

Official title: Randomized Intra-individually Controlled Double-blinded Trial Comparing Effect of Small Interfering RNA Against SPARC (siSPARC) Microneedle Patch Versus Small Interfering RNA Against SPARC and IL4-RA (siSPARC + siLR4A) Microneedle Patch on Appearance of Post-surgical Scars

This randomized, double-blind controlled study aims to compare the effect on appearance of post- surgical scars between daily application of siSPARC microneedle patch versus siSPARC + siLR4A microneedle patches. These are patches comprising short microneedles embedded with hydrolysed RNA (siRNAs).

Read the detailed description

This is an 8-week, single centre double-blinded intra-individually controlled trial to compare the effect of daily application of siSPARC microneedle patch versus siSPARC + siLR4A microneedle patch on post-surgical scars. At least 50 subjects will be recruited for the study. After the patients have been screened for study eligibility by the study investigators or coordinators, the subjects who have understood and signed the informed consent will be enrolled in the study. Provided a subject satisfies all inclusion criteria and does not fall within exclusion criteria during the screening visit, that subject will be started on the trial during that same visit. Computer-generated randomisation will be performed to determine the randomization of patient population to the siSPARC microneedle patch or siSPARC + siLR4A microneedle patch. Subsequent follow-up visits would be on Day 30 and Day 60. A deviation of +/- 7 days will be accepted during the follow-up. Each study visit will last between 30-60 minutes.

Study investigators and coordinators will be performing the following assessments:

  1. High resolution 3D imaging: Scar elevation will be measured using the Space Spider 3D scanner, with a resolution of 0.1 mm and a blue light-emitting diode (LED) light source;
  2. Vancouver scar scale (VSS) score;
  3. Scar Cosmesis Assessment and Rating (SCAR) scale score from the photographs;
  4. Change in patient-reported levels of pain and itch using a 11-point numerical rating scale; and
  5. Assessment of side effects (if any). Photographic documentation: Photographic documentation will be performed at baseline and during the specified follow-up examinations. Images will be taken with standardized camera settings and standardized positioning of the subject. These images will be assessed by investigators to assess the change in scar appearance.

The siRNA microneedle patches are not commercially available. These patches have undergone testing with guinea pigs and white rabbits and were ascertained as a 'non-sensitiser' and 'non- irritant', respectively. The patches have also underwent testing to L-929 cells which are adherent cells of mouse fibroblast cell line and found to be 'non-cytotoxic'. This study involves a trial comparing treatment outcomes; there is no investigative work conducted and hence no incidental findings are not anticipated.

Conditions
Keloid, Wound Heal, Wound
Being tested
siSPARC + siLR4A microneedle patches, siSPARC microneedle patch
Medical subject headings
Keloid, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • siSPARC + siLR4A microneedle patchesDrug

    Also called siSPARC + siLR4A microneedle patch

    siSPARC + siLR4A microneedle patch

  • siSPARC microneedle patchDrug

    Also called siSPARC + siLR4A microneedle patch

    siSPARC microneedle patch

Study groups in NCT06138964
Study groupRoleWhat they receive
siSPARC microneedle patchExperimentalsiSPARC microneedle patch
Receives: Drug: siSPARC microneedle patch
siSPARC + siLR4A microneedle patchExperimentalsiSPARC + siLR4A microneedle patch
Receives: Drug: siSPARC + siLR4A microneedle patches

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of post-surgical scar elevation

    To compare the efficacy in reducing post-surgical scar elevation between daily application of siSPARC microneedle patch versus siSPARC + siLR4A microneedle patch. This will be measured using high resolution 3D imaging: scar elevation will be measured using the Space Spider 3D scanner, with a resolution of 0.1 mm and a blue LED light source. The lower the elevation, the better the outcome.

    Measured: 1 year

Secondary outcomes (4)

  1. Assessment of Vancouver Scar Scale (VSS) score

    To evaluate the differences in VSS scores between daily application of siSPARC microneedle patch or siSPARC + siLR4A microneedle patch. The total VSS score is based on 4 points: (1) vascularity (on a scale of 0 being normal to 3 being purple); (2) pigmentation (on a scale of 0 being normal, to 2 being hyperpigmentation); (3) pliability (on a scale of 0 being normal to 5 being contractures); and (4) height (on a scale of normal being flat to 3 being >5mm). Higher scores indicate a worse outcome.

    Measured: 1 year

  2. Assessment of Scar Cosmesis Assessment and Rating (SCAR) Scale

    Assessment of SCAR Scale performed on photographs. The SCAR Scale is based on 8 points: (1) scar spread (on a scale of 0 being none to near-invisible to 4 being severe); (2) erythema (on a scale of 0 being none to 3 being deep red or purple); (3) dyspigmentation (being either 0 absent or 1 present); (4) track or suture marks (being either 0 absent or 1 present); (5) hypertrophy or atrophy (on a scale of 0 being none to 3 being severe); (6) impression (being either 0 desirable or 1 undesirable); (7) patient reported itch in last 24 hours (being either 0 absent or 1 present); and (8) patient reported pain (being either 0 absent or 1 present). Higher scores indicate a worse outcome.

    Measured: 1 year

  3. Patient-reported levels of pain and itch using a 11-point numerical rating scale

    Patient-reported levels of pain and itch using a 11-point numerical rating scale from 0 to 10 (0 being no pain, and 10 being the worst pain). Higher scores indicate a worse outcome.

    Measured: 1 year

  4. Side effects

    Patient reported side effects (if any), such as contact dermatitis (if any).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start14 Nov 2023
  3. Primary completion14 Nov 2024 (estimated)
  4. Study completion14 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06138964
Sponsor's protocol ID
2022/00942
Status last verified
Jun 2024
First submitted
9 Nov 2023
Last updated
24 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing siSPARC + siLR4A microneedle patches and siSPARC microneedle patch in people with Keloid and Wound Heal, run by National Skin Centre at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hong Liang Tey (6350 6666, teyhongliang@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of post-surgical scar elevation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06138964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.

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