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Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy

Phase 1
Waitlist Available
Research Sponsored by AiViva BioPharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing AIV001 to see if it can reduce scars and prevent keloids from coming back after surgery. It targets patients who have had keloids removed and aims to help their skin heal better.

Eligible Conditions
  • Keloid

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Secondary study objectives
Keloid recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: AIV001 Treatment Dose 2Experimental Treatment1 Intervention
Intradermal, Dose 2
Group II: AIV001 Treatment Dose 1Experimental Treatment1 Intervention
Intradermal, Dose 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AIV001
2018
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

AiViva BioPharma, Inc.Lead Sponsor
5 Previous Clinical Trials
75 Total Patients Enrolled
~6 spots leftby Dec 2025