An Exploratory Study to Evaluate the Safety and Efficacy of Intradermal Administration of AIV001 Aqueous Suspension on Scar Formation and Keloid Recurrence Following Keloidectomy

AIV001-W02

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

2021-06-23

2022-12-15

2022-12-15

Completed

Early phase I

25

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}

2023-03-30