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AIV001 for Keloid

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
Presence of one keloid scar, up to 2.2 cm length and up to 1.2 cm width, at least 1 year from formation, and located on trunk or arms
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights

Study Summary

This trial is testing a new treatment for scars to see if it is safe and effective.

Eligible Conditions
  • Keloid

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a raised scar (keloid) on your arms or trunk that is no larger than 2.2 cm long and 1.2 cm wide, and has been present for at least one year.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Secondary outcome measures
Keloid recurrence

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible for individuals to participate in the trial?

"Affirmative. According to clinicaltrials.gov, this research study is currently enrolling participants and was initially posted on June 23rd 2021. The most recent update occurred on May 11th 2022 and 30 people need to be recruited from 1 medical facility."

Answered by AI

Are mature individuals eligible to partake in this research?

"This study only accepts patients between the ages of 18-60. However, there are other trials available for minors (161 studies) and seniors (920 studies)."

Answered by AI

What criteria need to be met for someone to qualify as a participant of this research project?

"In order to be part of this research, subjects must have keloid scarring and lie in the age range 18-60. The total number of participants required is 30 individuals."

Answered by AI

Could you tell me what the uppermost limit of participants is for this clinical trial?

"Affirmative. Information available on clinicaltrials.gov indicates that this research project, which was published initially on June 23rd 2021, is actively recruiting participants . 30 patients are required to partake in the trial at 1 medical centre."

Answered by AI

What deleterious effects can be incurred by taking AIV001?

"Owing to the fact this is a Phase 1 trial, and there is therefore limited information on AIV001's efficacy or safety, our team has assigned it a score of 1."

Answered by AI
~7 spots leftby Mar 2025