Wound HealingON101 EfficacyNCT07854470
Efficacy of Early Postoperative ON101 Application for Lower-extremity Fracture Incisions: a Prospective Evaluator-blinded Controlled Study of Scar Quality and Digital-clinical Concordance
A study testing ON101 in people with Wound Healing, run by LIN Kai-Cheng at 1 site in Taiwan.
Trial summary
Background: Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- ON101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2024to 21 Mar 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgical suture wounds in patients aged 18-65 years with lower extremity or hip fractures.
- Suture wounds within three days after surgery.
- Those who have signed the informed consent form and must be able to follow the trial process.
Who cannot join
- Diabetics.
- Pregnant women or lactating mothers.
- Undergo systemic corticosteroid therapy/radiation therapy/immunosuppressive therapy.
- People who are suspected or known to have allergic reactions to the ingredients of this product, including centella asiatica, hand scented extracts or excipients.
- Infection with human immunodeficiency virus (HIV).
- Based on the subject's medical history, it is determined that the subject has a mental condition (such as suicidal ideation), current or chronic alcohol and drug addiction, which the trial moderator believes may have an impact on the subject's compliance with participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete epithelialization before use. Conversely, ON101 is a topical formulation. The formulation helps to maintain the wound moist environment, and the moist wound environment is conducive for wound healing. This profile suggests potential for earlier intervention. We evaluated whether initiating ON101 during the early postoperative repair phase improves subsequent wound healing and scar maturation.
Methods: This prospective, evaluator-blinded, controlled study enrolled 30 adults undergoing open reduction and internal fixation for lower-extremity fractures. Patients received once-daily topical ON101 (n=20) or standard care (n=10), initiated within 3 days postoperatively before complete epithelialization, and continued for 16 weeks. Blinded clinicians assessed scar maturation using the Vancouver Scar Scale (VSS). Standardized photographs were quantitatively analyzed using CIELab color parameters and gray-level co-occurrence matrix (GLCM) texture features.
Read the detailed description
Background: Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete epithelialization before use. Conversely, ON101 is a topical formulation. The formulation helps to maintain the wound moist environment, and the moist wound environment is conducive for wound healing. This profile suggests potential for earlier intervention. We evaluated whether initiating ON101 during the early postoperative repair phase improves subsequent wound healing and scar maturation.
Methods: This prospective, evaluator-blinded, controlled study enrolled 30 adults undergoing open reduction and internal fixation for lower-extremity fractures. Patients received once-daily topical ON101 (n=20) or standard care (n=10), initiated within 3 days postoperatively before complete epithelialization, and continued for 16 weeks. Blinded clinicians assessed scar maturation using the Vancouver Scar Scale (VSS). Standardized photographs were quantitatively analyzed using CIELab color parameters and gray-level co-occurrence matrix (GLCM) texture features.
- Conditions
- Wound Healing
- Being tested
- ON101
- Keywords
- ON101, fracture surgery, wound healing, scar quality, Vancouver Scar Scale, digital photography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON101Drug
Also called treatment group
starting at Day 0,once daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | once daily for 16 weeks Receives: Drug: ON101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale (VSS)
assesses pigmentation, vascularity, pliability, and scar height.
Measured: Because reliable assessment of height and pliability required suture removal and sufficient wound stabilization, VSS scoring began at V4 and continued through V8.
photographed
Observe changes in the wound
Measured: V2 (Day 0, baseline), V3 (Week 1), V4 (Week 2), V5 (Week 4), V6 (Week 8), V7 (Week 12), and V8 (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start10 Sep 2024
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study was designed as a prospective, evaluator-blinded, controlled study to investigate the effects of ON101 cream on post-surgical scarring following open reduction and internal fixation of lower extremity fractures (from hip to ankle). From January 2023 to October 2024, patients were enrolled at a single tertiary-referral medical center, where all surgeries were performed by the same orthopedic surgeon to ensure consistency in surgical technique and postoperative care. Eligible participants were adults aged 18-65 years who had undergone primary wound closure for clean surgical incisions resulting from lower extremity or hip fracture surgeries, with ON101 application within three days postoperatively. All participants provided written informed consent and were required to comply with the study protocol. Exclusion criteria included diabetes mellitus, pregnancy or lactation, ongoing systemic corticosteroid, radiation, or immunosuppressive therapy, known or suspected allergies to th
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LIN Kai-Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LIN Kai-Cheng, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854470
- Sponsor's protocol ID
- LKaiCheng
- Other IDs
- KSVGH22-CT11-16
- Acronym
- ON101 Efficacy
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal Data Protection Act
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Postoperative ON101 Application for Lower-extremity Fracture Incisions: a Prospective Evaluator-blinded Controlled Study of Scar Quality and Digital-clinical Concordance
- ClinicalTrials.gov ID
- NCT07854470
- Acronym / sponsor ID
- ON101 Efficacy / LKaiCheng
- Conditions
- Wound Healing
- Keywords
- ON101, fracture surgery, wound healing, scar quality, Vancouver Scar Scale, digital photography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LIN Kai-ChengUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete epithelialization before use. Conversely, ON101 is a topical formulation. The formulation helps to maintain the wound moist environment, and the moist wound environment is conducive for wound healing. This profile suggests potential for earlier intervention. We evaluated whether initiating ON101 during the early postoperative repair phase improves subsequent wound healing and scar maturation.
Methods: This prospective, evaluator-blinded, controlled study enrolled 30 adults undergoing open reduction and internal fixation for lower-extremity fractures. Patients received once-daily topical ON101 (n=20) or standard care (n=10), initiated within 3 days postoperatively before complete epithelialization, and continued for 16 weeks. Blinded clinicians assessed scar maturation using the Vancouver Scar Scale (VSS). Standardized photographs were quantitatively analyzed using CIELab color parameters and gray-level co-occurrence matrix (GLCM) texture features.
Detailed description
Background: Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete epithelialization before use. Conversely, ON101 is a topical formulation. The formulation helps to maintain the wound moist environment, and the moist wound environment is conducive for wound healing. This profile suggests potential for earlier intervention. We evaluated whether initiating ON101 during the early postoperative repair phase improves subsequent wound healing and scar maturation.
Methods: This prospective, evaluator-blinded, controlled study enrolled 30 adults undergoing open reduction and internal fixation for lower-extremity fractures. Patients received once-daily topical ON101 (n=20) or standard care (n=10), initiated within 3 days postoperatively before complete epithelialization, and continued for 16 weeks. Blinded clinicians assessed scar maturation using the Vancouver Scar Scale (VSS). Standardized photographs were quantitatively analyzed using CIELab color parameters and gray-level co-occurrence matrix (GLCM) texture features.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study was designed as a prospective, evaluator-blinded, controlled study to investigate the effects of ON101 cream on post-surgical scarring following open reduction and internal fixation of lower extremity fractures (from hip to ankle). From January 2023 to October 2024, patients were enrolled at a single tertiary-referral medical center, where all surgeries were performed by the same orthopedic surgeon to ensure consistency in surgical technique and postoperative care. Eligible participants were adults aged 18-65 years who had undergone primary wound closure for clean surgical incisions resulting from lower extremity or hip fracture surgeries, with ON101 application within three days postoperatively. All participants provided written informed consent and were required to comply with the study protocol. Exclusion criteria included diabetes mellitus, pregnancy or lactation, ongoing systemic corticosteroid, radiation, or immunosuppressive therapy, known or suspected allergies to th
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: ON101once daily for 16 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgical suture wounds in patients aged 18-65 years with lower extremity or hip fractures.
- Suture wounds within three days after surgery.
- Those who have signed the informed consent form and must be able to follow the trial process.
Key exclusion criteria (6 listed)
- Diabetics.
- Pregnant women or lactating mothers.
- Undergo systemic corticosteroid therapy/radiation therapy/immunosuppressive therapy.
- People who are suspected or known to have allergic reactions to the ingredients of this product, including centella asiatica, hand scented extracts or excipients.
- Infection with human immunodeficiency virus (HIV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ON101Also: treatment groupstarting at Day 0,once daily for 16 weeks. | Drug | treatment group |
Primary outcome
Vancouver Scar Scale (VSS)
Time frame: Because reliable assessment of height and pliability required suture removal and sufficient wound stabilization, VSS scoring began at V4 and continued through V8.
assesses pigmentation, vascularity, pliability, and scar height.
photographed
Time frame: V2 (Day 0, baseline), V3 (Week 1), V4 (Week 2), V5 (Week 4), V6 (Week 8), V7 (Week 12), and V8 (Week 16)
Observe changes in the wound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Personal Data Protection Act
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ON101 in people with Wound Healing, run by LIN Kai-Cheng at 1 site in Taiwan.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 Oct 2026. 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) (time frame: Because reliable assessment of height and pliability required suture removal and sufficient wound stabilization, VSS scoring began at V4 and continued through V8.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.