ScarPhase 2NCT05838833
Ointment to Prevent Scar After Thyroidectomy
A Phase 2 study testing INV-001 in people with Scar, run by Innovo Therapeutics, Inc. at 1 site in South Korea.
Trial summary
The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy. Participants will be asked to apply ointment on their scar for 12 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Scar
- What is being tested?
- INV-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2023to Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who got thyroidectomy due to Thyroid cancer
- has scar longer than 3 cm
Who cannot join
- have history about Keloid or Hypertrophic scar
- have infection on surgical site
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Innovo Therapeutics, Inc.
Seoul
Minjeong Kim, Master, +82-2-6956-8680, mjkim@innovothera.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of INV-001 Administration for the Prevention of Scar After Thyroidectomy
The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy.
Participants will be asked to apply ointment on their scar for 12 weeks.
Read the detailed description
to evaluate the efficacy
-investigator check POSAS and VSS
- Conditions
- Scar
- Being tested
- INV-001
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-001Drug
Patient will be assigned to one of three arms.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | low dose ointment Receives: Drug: INV-001 |
| High dose | Experimental | high dose ointment Receives: Drug: INV-001 |
| Placebo | Placebo comparator | same ingredient with active drug except API Receives: Drug: INV-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observer overall opinion of POSAS
POSAS POSAS: Patient Observer Scar Assessment Scale
Measured: 12 weeks
Secondary outcomes (1)
Observer overall opinion of POSAS
POSAS: Patient Observer Scar Assessment Scale
Measured: 3, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start14 Feb 2023
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minjeong Kim, Master, Study director, New Drug development Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838833
- Sponsor's protocol ID
- INV001-01
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of INV-001 Administration for the Prevention of Scar After Thyroidectomy
- ClinicalTrials.gov ID
- NCT05838833
- Acronym / sponsor ID
- INV001-01
- Conditions
- Scar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Innovo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 May 2023 (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.
The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy.
Participants will be asked to apply ointment on their scar for 12 weeks.
Detailed description
to evaluate the efficacy
-investigator check POSAS and VSS
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: INV-001low dose ointment |
| High dose | Experimental | Drug: INV-001high dose ointment |
| Placebo | Placebo comparator | Drug: INV-001same ingredient with active drug except API |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who got thyroidectomy due to Thyroid cancer
- has scar longer than 3 cm
Key exclusion criteria (2 listed)
- have history about Keloid or Hypertrophic scar
- have infection on surgical site
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 |
|---|---|---|
| INV-001Patient will be assigned to one of three arms. | Drug | High dose, Low dose, Placebo |
Primary outcome
Observer overall opinion of POSAS
Time frame: 12 weeks
POSAS POSAS: Patient Observer Scar Assessment Scale
1 secondary outcome
Observer overall opinion of POSAS
Time frame: 3, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Minjeong Kim, Master study director
New Drug development Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INV-001 in people with Scar, run by Innovo Therapeutics, Inc. at 1 site in South Korea.
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 2 inclusion and 2 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 3 May 2023. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 Minjeong Kim, Master (82-2-6956-8680, mjkim@innovothera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observer overall opinion of POSAS (time frame: 12 weeks). 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 3 May 2023; AzTrials last refreshed its copy on 29 Oct 2026.