A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision

Completed · Phase 1/Phase 2

Conditions studied: Scar, Incision, Abdominal, Wound (Morphologic Abnormality)

In brief

To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds

Key facts

Study ID

NCT03639883

Run by

AiViva BioPharma, Inc.

People needed

16

Starts

2018-11-05

Expected to finish

2019-12-19

Last updated by the study team

2024-12-24

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligible for an abdominoplasty
• Nonsmoker
• Fitzpatrick I-IV
• Weight >45Kg
• BMI <= 35

You may not qualify if…

• Existing scars in study area, active infection
• Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study

Where it is running

• Kaufman and Davis Plastic Surgery — Folsom, California, United States
• Cosmetic Laser Dermatology — San Diego, California, United States

Full record on ClinicalTrials.gov

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