NCT05838833

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

March 29, 2023

Last Update Submit

April 19, 2023

Conditions

Scar

Outcome Measures

Primary Outcomes (1)

  • Observer overall opinion of POSAS

    POSAS POSAS: Patient Observer Scar Assessment Scale

    12 weeks

Secondary Outcomes (1)

  • Observer overall opinion of POSAS

    3, 6 weeks

Study Arms (3)

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

INV-001DRUG

Patient will be assigned to one of three arms.

High doseLow dosePlacebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovo Therapeutics, Inc.

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Minjeong Kim, Master

    New Drug development Center

    STUDY DIRECTOR

Central Study Contacts

Minjeong Kim, Master

CONTACT

82-2-6956-8680mjkim@innovothera.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

May 3, 2023

Study Start

February 14, 2023

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

KR(1)