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Completed

NCT Number: NCT03639883

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

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

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Key information

Conditions

Scar Abdominal Cicatrix Fibrosis Incision Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Wound Wound (Morphologic Abnormality) Wounds and Injuries

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kaufman and Davis Plastic Surgery, Folsom, California, United States

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About this study

This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

AIV001

Drug

Intradermal injection

Other names: AIV001 suspension

Primary outcomes

  1. Adverse events

    Time frame: Day 1 through Day 49

    Local and systemic adverse events

Secondary outcomes

  1. Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)

    Time frame: Day 7 through 49

    Evaluation of the healing of the wounds

  2. Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)

    Time frame: Day 7 through 49

    Evaluation of the healing wounds

  3. 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)

    Time frame: Day 7 through 49

    Evaluation of healing wounds

Sponsors and collaborators

Lead sponsor

AiViva BioPharma, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Vehicle-controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intradermally Administered AIV001 in Healing of Incisional Wounds

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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