Status:
COMPLETED
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
Lead Sponsor:
AiViva BioPharma, Inc.
Conditions:
Keloid
Scar
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 op...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04827875
Start Date
June 23 2021
End Date
December 15 2022
Last Update
December 27 2024
Active Locations (4)
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1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
2
Skin Research Institute
Coral Gables, Florida, United States, 33146
3
DermResearch DRI
Austin, Texas, United States, 78759
4
J&S Studies
College Station, Texas, United States, 77845