Clinical trial

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

Name

INV001-01

Description

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 arms

Trial start

2023-02-14

Estimated PCD

2023-12-01

Trial end

2024-06-01

Status

Recruiting

Phase

Early phase I

Treatment

INV-001

Patient will be assigned to one of three arms.

Arms:

High dose, Low dose, Placebo

Size

Primary endpoint

Observer overall opinion of POSAS

12 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

Updated at

2023-05-03

1 organization

1 product

1 indication

Organization

Innovo Therapeutics

Product

INV-001

Indication

Scar