Scar Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 75 |
| Est. completion date | June 2024 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Innovo Therapeutics, Inc. | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Innovo Therapeutics, Inc. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Observer overall opinion of POSAS | POSAS POSAS: Patient Observer Scar Assessment Scale | 12 weeks | |
| Secondary | Observer overall opinion of POSAS | POSAS: Patient Observer Scar Assessment Scale | 3, 6 weeks |
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