Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy (NCT04827875) | Clinical Trial Compass
CompletedPhase 1
Safety and Efficacy of AIV001 on Scar Formation and Keloid Recurrence Following Keloidectomy
United States25 participantsStarted 2021-06-23
Plain-language summary
To evaluate the saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy.
Who can participate
Age range18 Years – 60 Years
SexALL
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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