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Also known as Small interfering RNA (siRNA) Microneedle Patches
Small interfering RNA Microneedle Patches · 1 trial · 1 indication
The Vancouver Scar Scale (VSS) is a validated clinician-reported instrument that is a measure of scar severity comprising 4 domains assessing scar appearance and physical characteristics. The scale evaluates Vascularity (from 0 to 3), Pigmentation (from 0 to 2), Pliability (from 0 to 5) and Height (from 0 to 3). Each domain is assigned an individual score and combined to provide a total scar severity score ranging from 0 to 13, with higher values representing greater scar severity and poorer scar appearance. Changes in score over time may be used to assess response to treatment, with reductions in score representing clinical improvement. Score at baseline (post-surgical scar immediately post CO2 laser surgery) and at each review visit will be compared.
The Scar Cosmesis Assessment and Rating (SCAR) scale is a validated clinician-reported instrument that is a measure of post-surgical scar quality comprising multiple domains assessing scar appearance, symptoms, and overall cosmetic outcome. The scale evaluates Scar Spread (from 0 to 4), Erythema (from 0 to 3), Dyspigmentation (from 0 to 2), Track or suture marks (from 0 to 1), Hypertrophy or atrophy (from 0 to 3), Overall impression (from 0 to 1), and patient rated bothersome itch and pain over the preceding 24 hours (Yes or No). Individual domain scores are combined to provide a total assessment of scar severity and cosmesis, with higher values representing poorer scar appearance and greater symptom burden. Changes in score over time may be used to assess response to treatment, with reductions in score representing clinical improvement. Score at baseline (post-surgical scar immediately post CO2 laser surgery) and at each review visit will be compared.
| Arm | Type | Description |
|---|---|---|
| CO2 laser surgery followed by intralesional steroid injection | ACTIVE_COMPARATOR | In the active comparator arm, participants are first treated with CO2 laser surgery of the earlobe keloid. The first dose of intralesional steroid injection is given immediately to the wound bed post-surgery, followed by subsequent doses of intralesional steroid injection administered at monthly intervals for four doses in total. |
| CO2 laser surgery followed by intralesional steroids and siRNA microneedle patches | EXPERIMENTAL | In the experimental arm, participants are first treated with CO2 laser surgery of the earlobe keloid. The first dose of intralesional steroid injection is given immediately to the wound bed post-surgery, followed by subsequent doses of intralesional steroid injection administered at monthly intervals for four doses in total. In addition, participants will apply siRNA microneedle patches for 10 hours per day for 90 days in total except on days where intralesional steroid injection is given to permit healing at puncture site. |
| Name | Type | Description |
|---|---|---|
| Small interfering RNA (siRNA) Microneedle Patches | DRUG | Silencing or small interfering RNA (siRNA) are used to alter the expression of transforming growth factor secreted protein acidic and cysteine-rich (SPARC), a key mediator of wound fibrosis and keloid scar formation. Conjugating siRNA targeting SPARC mRNA with tyramine-modified gelatin to form a positively-charged nanoplex can help to enable siRNA protection against rapid in-vivo degradation, promoting uptake into fibroblasts via endocytosis, and enhacing targeted cellular delivery of the siRNA. These siRNA nanoplexes targeting SPARC mRNA are embedded in the tips of hyaluronic acid dissolvable microneedles (siRNA microneedles) to enhance transcutaneous drug delivery. In this study, participants in the experimental arm will apply siRNA microneedle patches daily for 10 hours a day in between monthly doses of intralesional corticosteroid injection for 90 days in total. |
| Carbon Dioxide (CO2) Laser Surgery | PROCEDURE | Carbon Dioxide (CO2) laser ablation of the earlobe keloid will be performed, followed by intralesional corticosteroid injections alone (active comparator arm) or with siRNA microneedle patches (experimental arm) |
| Intralesional Triamcinolone 40 mg/mL | DRUG | Intralesional triamcinolone 40mg/ml injection. The first dose is given immediately to the wound bed post-surgery, then at monthly intervals for four doses in total. |
Inclusion Criteria: * ≥21 years old * Not pregnant, breastfeeding or lactating * Able to give consent to participate in trial * Keloid on the earlobe * One keloid recruited per patient * For patients with bilateral earlobe keloids, only one earlobe keloid will be recruited (either left or right)...
Small interfering RNA Microneedle Patches are used for the treatment of keloid of the ear lobe, specifically for post-surgical scars. The therapy is being developed as an active-controlled treatment and is currently in Phase 2 clinical development.
Small interfering RNA Microneedle Patches are being developed by National Healthcare Corp., which trades under the ticker NHC. The company is conducting a Phase 2 clinical trial for this investigational therapy.
Small interfering RNA Microneedle Patches are in Phase 2 clinical development. The therapy is investigational and has not yet been approved by regulatory authorities. It is being studied for the treatment of keloid of the ear lobe.
Small interfering RNA Microneedle Patches are being evaluated in one Phase 2 clinical trial, identified as NCT07596628. This trial, titled 'siRNA Microneedle Patches for Earlobe Keloid Post-Surgical Scars,' is not yet recruiting and plans to enroll 158 participants in Singapore.
Yes, Small interfering RNA Microneedle Patches are also known as Small interfering RNA (siRNA) Microneedle Patches. Both names refer to the same investigational therapy being developed by National Healthcare Corp. for keloid of the ear lobe.
The Phase 2 clinical trial for Small interfering RNA Microneedle Patches, NCT07596628, is a randomized, active-controlled study. It is not double-blind and does not use biomarker selection. The trial is planned to enroll 158 participants aged 21 years and older in Singapore.