A Safety and Efficacy Study to Evaluate Wound Healing

July 10, 2020 updated by: AiViva BioPharma, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Cosmetic Laser Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 0.033% versus Vehicle
One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.
Drug: AIV001
Intradermal injection
Other Names:
  • AIV001 suspension
Placebo Comparator: 0.1% versus Vehicle
One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.
Drug: AIV001
Intradermal injection
Other Names:
  • AIV001 suspension
Placebo Comparator: 0.3% versus Vehicle
One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.
Drug: AIV001
Intradermal injection
Other Names:
  • AIV001 suspension
Placebo Comparator: 1% versus Vehicle
One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.
Drug: AIV001
Intradermal injection
Other Names:
  • AIV001 suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Day 1 through Day 49
Local and systemic adverse events
Day 1 through Day 49

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 7 through 49
Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)
Time Frame: Day 7 through 49
Evaluation of the healing wounds
Day 7 through 49
100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)
Time Frame: Day 7 through 49
Evaluation of healing wounds
Day 7 through 49

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AiViva BioPharma, Inc.

Investigators

  • Study Director: James Milbauer, MD, Novella Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2018

Primary Completion (Actual)

December 4, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIV001-W01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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