Ointment to Prevent Scar After Thyroidectomy | NCT05838833

Studies
Ointment to Prevent Scar After Thyroidectomy

NCT05838833

Sponsor

Innovo Therapeutics, Inc.

Status

Unknown status

Last Update Posted

May 3, 2023Actual

Enrollment

75Estimated

Phase

Phase 2

Conditions

Scar

Interventions

INV-001

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2023Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

Mar 29, 2023

First Submission Date that Met QC Criteria

Apr 19, 2023

First Posted Date

May 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

May 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

to evaluate the efficacy

-investigator check POSAS and VSS

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose	Experimental	low dose ointment	Drug: INV-001
High dose	Experimental	high dose ointment	Drug: INV-001
Placebo	Placebo Comparator	same ingredient with active drug except API	Drug: INV-001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INV-001	Drug	Patient will be assigned to one of three arms.	High dose Low dose Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Observer overall opinion of POSAS	POSAS POSAS: Patient Observer Scar Assessment Scale	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Observer overall opinion of POSAS	POSAS: Patient Observer Scar Assessment Scale	3, 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who got thyroidectomy due to Thyroid cancer
has scar longer than 3 cm

Exclusion Criteria:

have history about Keloid or Hypertrophic scar
have infection on surgical site

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Minjeong Kim, Master	Contact	82-2-6956-8680		mjkim@innovothera.com

Overall Officials

Name	Affiliation	Role
Minjeong Kim, Master	New Drug development Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Innovo Therapeutics, Inc.	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Feb 7, 2025
Reset	Feb 26, 2025
Release	Mar 12, 2025
Reset	Mar 28, 2025
Release	Apr 2, 2025
Reset	Apr 18, 2025

Submission Tracking

Estimated Results First Submitted Date

Feb 7, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 7, 2025			Feb 26, 2025
Mar 12, 2025

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided