Ointment to Prevent Scar After Thyroidectomy

April 19, 2023 updated by: Innovo Therapeutics, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

to evaluate the efficacy

-investigator check POSAS and VSS

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose
low dose ointment
Drug: INV-001
Patient will be assigned to one of three arms.
Experimental: High dose
high dose ointment
Drug: INV-001
Patient will be assigned to one of three arms.
Placebo Comparator: Placebo
same ingredient with active drug except API
Drug: INV-001
Patient will be assigned to one of three arms.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovo Therapeutics, Inc.

Investigators

  • Study Director: Minjeong Kim, Master, New Drug development Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • INV001-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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