Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
Completed · Phase 1
Conditions studied: Keloid, Scar, Incision, Excision Margin
In brief
To evaluate the saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy.
Key facts
- Study ID
- NCT04827875
- Run by
- AiViva BioPharma, Inc.
- People needed
- 25
- Starts
- 2021-06-23
- Expected to finish
- 2022-12-15
- Last updated by the study team
- 2024-12-27
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- California Dermatology & Clinical Research Institute — Encinitas, California, United States
- Skin Research Institute — Coral Gables, Florida, United States
- DermResearch DRI — Austin, Texas, United States
- J&S Studies — College Station, Texas, United States
Full record on ClinicalTrials.gov
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