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

NCT ID: NCT03639883

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-12-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Scar Incision Abdominal Wound (Morphologic Abnormality)

Keywords

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wound healing Scar abdominoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized, double-blind, vehicle-controlled, dose-escalation
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Treating investigator will administer the study medication. Evaluating Investigator will perform the safety and efficacy evaluations.

Study Groups

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0.033% versus Vehicle

One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.

Group Type EXPERIMENTAL

AIV001

Intervention Type DRUG

Intradermal injection

0.1% versus Vehicle

One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.

Group Type EXPERIMENTAL

AIV001

Intervention Type DRUG

Intradermal injection

0.3% versus Vehicle

One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.

Group Type EXPERIMENTAL

AIV001

Intervention Type DRUG

Intradermal injection

1% versus Vehicle

One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.

Group Type EXPERIMENTAL

AIV001

Intervention Type DRUG

Intradermal injection

Interventions

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AIV001

Intradermal injection

Intervention Type DRUG

Other Intervention Names

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AIV001 suspension

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AiViva BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Milbauer, MD

Role: STUDY_DIRECTOR

Novella Clinical

Locations

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Kaufman and Davis Plastic Surgery

Folsom, California, United States

Site Status

Cosmetic Laser Dermatology

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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AIV001-W01

Identifier Type: -

Identifier Source: org_study_id