ScarPhase 1NCT03639883
A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision
A Phase 1 study testing AIV001 in people with Scar and Incision, run by AiViva BioPharma, Inc. at 2 sites in United States.
Trial summary
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- What is being tested?
- AIV001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Nov 2018to 19 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible for an abdominoplasty
- Nonsmoker
- Fitzpatrick I-IV
- Weight >45Kg
- BMI <= 35
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaufman and Davis Plastic Surgery
Folsom, California, 95630
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official 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
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
Read the detailed description
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
- Scar, Incision, Abdominal, Wound (Morphologic Abnormality)
- Being tested
- AIV001
- Keywords
- wound healing, Scar, abdominoplasty
- Medical subject headings
- Cicatrix, Surgical Wound, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIV001Drug
Also called AIV001 suspension
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| 0.033% versus Vehicle | Experimental | One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle. Receives: Drug: AIV001 |
| 0.1% versus Vehicle | Experimental | One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle. Receives: Drug: AIV001 |
| 0.3% versus Vehicle | Experimental | One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle. Receives: Drug: AIV001 |
| 1% versus Vehicle | Experimental | One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle. Receives: Drug: AIV001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Local and systemic adverse events
Measured: Day 1 through Day 49
Secondary outcomes (3)
Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)
Evaluation of the healing of the wounds
Measured: Day 7 through 49
Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)
Evaluation of the healing wounds
Measured: Day 7 through 49
100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)
Evaluation of healing wounds
Measured: Day 7 through 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start5 Nov 2018
- Primary completion4 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, double-blind, vehicle-controlled, dose-escalation
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiViva BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Milbauer, MD, Study director, Novella Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639883
- Sponsor's protocol ID
- AIV001-W01
- Status last verified
- Nov 2026
- First submitted
- 16 Aug 2018
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03639883
- Acronym / sponsor ID
- AIV001-W01
- Conditions
- Scar, Incision, Abdominal, Wound (Morphologic Abnormality)
- Keywords
- wound healing, Scar, abdominoplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AiViva BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blind, vehicle-controlled, dose-escalation
| Arm | Type | Receives |
|---|---|---|
| 0.033% versus Vehicle | Experimental | Drug: AIV001One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle. |
| 0.1% versus Vehicle | Experimental | Drug: AIV001One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle. |
| 0.3% versus Vehicle | Experimental | Drug: AIV001One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle. |
| 1% versus Vehicle | Experimental | Drug: AIV001One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Eligible for an abdominoplasty
- Nonsmoker
- Fitzpatrick I-IV
- Weight >45Kg
- BMI <= 35
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIV001Also: AIV001 suspensionIntradermal injection | Drug | 0.033% versus Vehicle, 0.1% versus Vehicle, 0.3% versus Vehicle, 1% versus Vehicle |
Primary outcome
Adverse events
Time frame: Day 1 through Day 49
Local and systemic adverse events
3 secondary outcomes
Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)
Time frame: Day 7 through 49
Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)
Time frame: Day 7 through 49
100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)
Time frame: Day 7 through 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Milbauer, MD study director
Novella Clinical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AIV001 in people with Scar and Incision, run by AiViva BioPharma, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Day 1 through Day 49). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.