KeloidPhase 1NCT04827875
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
A Phase 1 study testing AIV001 in people with Keloid and Scar, run by AiViva BioPharma, Inc. at 4 sites in United States.
Trial summary
To evaluate the saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- AIV001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jun 2021to 15 Dec 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male of female, aged 18 to 60, inclusive
- No clinically relevant abnormalities identified by a detailed medical history and vital signs
- Presence of one keloid scar, up to 2.2 cm length and up to 1.2 cm width, at least 1 year from formation, and located on trunk or arms
- Willing to undergo surgical excision of keloid
- No concurrent treatment of the study keloid or prior treatment within last 2 months
Who cannot join
- Prior keloidectomy of study keloid
- History of genetic disorder that predisposes to keloids (e.g., Ehlers-Danlos syndrome, Ullrich congenital muscular dystrophy, etc.)
- Corticosteroids (topical, injectable, inhalable, intranasal, or oral) within last two months (except as prescribed by physician for seasonal allergies)
- Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results
- History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula
- Subject has active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura
Trial locations and contacts
4 sites in 1 country.
United States4 sites
DermResearch DRI
Austin, Texas, 78759
J&S Studies
College Station, Texas, 77845
Skin Research Institute
Coral Gables, Florida, 33146
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
About this study
Official title: An Exploratory Study to Evaluate the Safety and Efficacy of Intradermal Administration of AIV001 Aqueous Suspension on Scar Formation and Keloid Recurrence Following Keloidectomy
To evaluate the saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy.
Read the detailed description
AIV001 (axitinib) has been formulated to provide focal disease-modifying therapy for patients undergoing surgical procedures where scar formation will occur. This was a multicenter, dose-escalation open label study to assess the safety and efficacy of AIV001 on scar formation and/or keloid recurrence following keloidectomy. This study design is an evaluation of surgical excision of keloid scar tissue followed by AIV001 intradermal injection. On Day 1, following keloidectomy, the incision area (devoid of keloid scar tissue) was sutured, creating an incision line. The incision line is the area of scar formation and assessment. This is a variable dose study defined by incision line length. The incision line length measurement defined each subject's AIV001 treatment based on the dose plan table in the protocol. Subjects received a minimum of 1 and up to 3 treatments, dependent on the protocol amendment implemented at the time of their participation and PI discretion based upon safety assessments. The excised tissue was sent to pathology for confirmation of keloid scar tissue. The treatment interval was Day 1 to Day 30 visits with observation visits on Days 60, 90, 183, and 365. A safety data review was conducted after the first 3 subjects in Cohort 1 completed the Day 30 visit. Assessment of local skin reactions (LSRs), wound healing, vitals, treatment-emergent adverse events (TEAEs) and pre-defined dose-limiting toxicities (DLTs) were reviewed to determine whether additional subjects were permitted to be enrolled. If safety was deemed acceptable, enrollment into Cohort 1 continued and Cohort 2 was open for enrollment. The same safety data review was conducted at Day 30 visit for the first 3 subjects enrolled in Cohort 2. The open-label study design allowed for adjustments to the dosing regimen (timing and frequency of dosing) based on review of each consecutive dosing cohort.
- Conditions
- Keloid, Scar, Incision, Excision Margin
- Being tested
- AIV001
- Keywords
- Scar formation, Keloidectomy
- Medical subject headings
- Keloid, Cicatrix, Surgical Wound, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIV001Drug
Intradermal
| Study group | Role | What they receive |
|---|---|---|
| AIV001 Treatment Dose 1 | Experimental | Intradermal, Dose 1 Receives: Drug: AIV001 |
| AIV001 Treatment Dose 2 | Experimental | Intradermal, Dose 2 Receives: Drug: AIV001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence of adverse events
Measured: Approximately 365 days
Secondary outcomes (2)
Keloid recurrence
Number of subjects experiencing keloid recurrence within study duration
Measured: 365 days
Modified Vancouver Scar Scale (mVSS)
Modified Vancouver Scar Scale (mVSS) includes four categories of scar quality (i.e., pliability (0-4), height (0-4), vascularity (0-3), and pigmentation (0-3)), with 0 representing normal body skin. The composite mVSS scar score (ranges 0-14) is the sum of the 4 category scores to represent the overall scar quality.
Measured: Day 90 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start23 Jun 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Excisions of existing keloid scar, treatment of incisional area followed by evaluation of scar formation overtime.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiViva BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827875
- Sponsor's protocol ID
- AIV001-W02
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Safety and Efficacy of Intradermal Administration of AIV001 Aqueous Suspension on Scar Formation and Keloid Recurrence Following Keloidectomy
- ClinicalTrials.gov ID
- NCT04827875
- Acronym / sponsor ID
- AIV001-W02
- Conditions
- Keloid, Scar, Incision, Excision Margin
- Keywords
- Scar formation, Keloidectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AiViva BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 1 Apr 2021 (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 saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy.
Detailed description
AIV001 (axitinib) has been formulated to provide focal disease-modifying therapy for patients undergoing surgical procedures where scar formation will occur. This was a multicenter, dose-escalation open label study to assess the safety and efficacy of AIV001 on scar formation and/or keloid recurrence following keloidectomy. This study design is an evaluation of surgical excision of keloid scar tissue followed by AIV001 intradermal injection. On Day 1, following keloidectomy, the incision area (devoid of keloid scar tissue) was sutured, creating an incision line. The incision line is the area of scar formation and assessment. This is a variable dose study defined by incision line length. The incision line length measurement defined each subject's AIV001 treatment based on the dose plan table in the protocol. Subjects received a minimum of 1 and up to 3 treatments, dependent on the protocol amendment implemented at the time of their participation and PI discretion based upon safety assessments. The excised tissue was sent to pathology for confirmation of keloid scar tissue. The treatment interval was Day 1 to Day 30 visits with observation visits on Days 60, 90, 183, and 365. A safety data review was conducted after the first 3 subjects in Cohort 1 completed the Day 30 visit. Assessment of local skin reactions (LSRs), wound healing, vitals, treatment-emergent adverse events (TEAEs) and pre-defined dose-limiting toxicities (DLTs) were reviewed to determine whether additional subjects were permitted to be enrolled. If safety was deemed acceptable, enrollment into Cohort 1 continued and Cohort 2 was open for enrollment. The same safety data review was conducted at Day 30 visit for the first 3 subjects enrolled in Cohort 2. The open-label study design allowed for adjustments to the dosing regimen (timing and frequency of dosing) based on review of each consecutive dosing cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Excisions of existing keloid scar, treatment of incisional area followed by evaluation of scar formation overtime.
| Arm | Type | Receives |
|---|---|---|
| AIV001 Treatment Dose 1 | Experimental | Drug: AIV001Intradermal, Dose 1 |
| AIV001 Treatment Dose 2 | Experimental | Drug: AIV001Intradermal, Dose 2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male of female, aged 18 to 60, inclusive
- No clinically relevant abnormalities identified by a detailed medical history and vital signs
- Presence of one keloid scar, up to 2.2 cm length and up to 1.2 cm width, at least 1 year from formation, and located on trunk or arms
- Willing to undergo surgical excision of keloid
- No concurrent treatment of the study keloid or prior treatment within last 2 months
Key exclusion criteria (6 listed)
- Prior keloidectomy of study keloid
- History of genetic disorder that predisposes to keloids (e.g., Ehlers-Danlos syndrome, Ullrich congenital muscular dystrophy, etc.)
- Corticosteroids (topical, injectable, inhalable, intranasal, or oral) within last two months (except as prescribed by physician for seasonal allergies)
- Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results
- History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula
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 |
|---|---|---|
| AIV001Intradermal | Drug | AIV001 Treatment Dose 1, AIV001 Treatment Dose 2 |
Primary outcome
Adverse events
Time frame: Approximately 365 days
Incidence of adverse events
2 secondary outcomes
Keloid recurrence
Time frame: 365 days
Modified Vancouver Scar Scale (mVSS)
Time frame: Day 90 and Day 180
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 27 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Keloid and Scar, run by AiViva BioPharma, Inc. at 4 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 6 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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: Approximately 365 days). 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 27 Dec 2024.