A Phase 1 interventional study of AIV001 in Keloid, Scar and Incision, sponsored by AiViva BioPharma, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by AiViva BioPharma, Inc. · Phase 1, Interventional, and Prevention
To evaluate the saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy.
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 25 is below the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →AiViva BioPharma, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intradermal, Dose 1
Drug: AIV001
Intradermal, Dose 2
Drug: AIV001
Intradermal
Adverse events
Incidence of adverse events
Time frame: Approximately 365 days
Keloid recurrence
Number of subjects experiencing keloid recurrence within study duration
Time frame: 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.
Time frame: Day 90 and Day 180
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Multi-kinase Inhbitor AIV001
AiViva BioPharma, Inc.