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Efficacy and safety of polynucleotide injection for the treatment of hypertrophic scars and keloids on abdomen: a randomized, double-blinded, split-scar study

Efficacy and safety of polynucleotide injection for the treatment of hypertrophic scars and keloids on abdomen: a randomized, double-blinded, split-scar study

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240630003
Enrollment
25
Registered
2024-06-30
Start date
2024-02-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic and keloid scars Hypertrophic scars, keloid scars, polynucleotide, steroid injection

Interventions

Participants will be randomly assigned using the Block Randomization method to receive either polynucleotide injection Rejuran,or Triamcinolone acetonide 10mg/ml on Side B of the surgical scar area.
Experimental Drug,Active Comparator Drug
Polynucleotide,Triamcinolone acetonide

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: To be eligible for the study, participants must be 18 years or older and generally healthy without severe chronic illnesses. They should have hypertrophic or keloid scars on their abdomen in a linear fashion and be able to attend scheduled medical appointments and adhere to study procedures. Additionally, they must be willing to participate by providing informed consent.

Exclusion criteria

Exclusion criteria: However, individuals are excluded from the study if they have received scar treatments involving injections or laser therapy within the past three months, used silicone sheeting on the scar area at the time of enrollment, or have a history or suspicion of skin infection in the treatment area. Other exclusion criteria include being immunocompromised, having a history of skin cancer, herpes simplex virus infection affecting the skin, abnormal tissue growth disorders, or being pregnant or breastfeeding. Lastly, those who refuse or withdraw consent to participate are also excluded.

Design outcomes

Primary

MeasureTime frame
Efficacy and safety of polynucleotide injection for the treatment of hypertrophic scars and keloids on abdomen 5months Scar volume, redness, darkness, and height will be measured using Antera 3D

Secondary

MeasureTime frame
side effect 5 months redness, swelling, skin peeling, dark spots, and white spots will be assessed by both dermatologists and participants after treatment and at each follow-up visit.

Countries

Thailand

Contacts

Public ContactPimsiri Anansiripun

Ramathibodi hospital

pimsiri.anan@gmail.com0882522836

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026