Back to resultsSafety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
Primary Purpose
Keloid
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AIV001
Sponsored by
About this trial
This is an interventional prevention trial for Keloid focused on measuring Scar formation, Keloidectomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- California Dermatology & Clinical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AIV001 Treatment Dose 1
AIV001 Treatment Dose 2
Arm Description
Intradermal, Dose 1
Intradermal, Dose 2
Outcomes
Primary Outcome Measures
Adverse events
Incidence of adverse events
Secondary Outcome Measures
Keloid recurrence
Number of subjects experiencing keloid recurrence within study duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04827875
Brief Title
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AiViva BioPharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate how safe and effective AIV001 treatment is on scar formation and/or keloid recurrence following keloidectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Scar formation, Keloidectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIV001 Treatment Dose 1
Arm Type
Experimental
Arm Description
Intradermal, Dose 1
Arm Title
AIV001 Treatment Dose 2
Arm Type
Experimental
Arm Description
Intradermal, Dose 2
Intervention Type
Drug
Intervention Name(s)
AIV001
Intervention Description
Intradermal
Primary Outcome Measure Information:
Title
Adverse events
Description
Incidence of adverse events
Time Frame
Approximately 365 days
Secondary Outcome Measure Information:
Title
Keloid recurrence
Description
Number of subjects experiencing keloid recurrence within study duration
Time Frame
365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
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