Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate how safe and effective AIV001 treatment is on scar formation and/or keloid recurrence following keloidectomy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AiViva BioPharma, Inc.

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