Ointment to Prevent Scar After Thyroidectomy

Phase 2

Recruiting

• Conditions: Scar
• Interventions: Drug: INV-001

• Registration Number: NCT05838833
• Lead Sponsor: Innovo Therapeutics, Inc.

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

Study Timeline

• Study Start: 2023-02-14
• Study First Submitted: 2023-03-29
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	INV-001	low dose ointment
Placebo	INV-001	same ingredient with active drug except API
High dose	INV-001	high dose ointment

Primary Outcome Measures

Name	Time	Method
Observer overall opinion of POSAS	12 weeks	POSAS POSAS: Patient Observer Scar Assessment Scale

Secondary Outcome Measures

Name	Time	Method
Observer overall opinion of POSAS	3, 6 weeks	POSAS: Patient Observer Scar Assessment Scale

Trial Locations

Locations (1)

Innovo Therapeutics, Inc.; 🇰🇷 Seoul, Korea, Republic of