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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827875
• Other study ID #: AIV001-W02
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: AiViva BioPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Keloid
• Recurrence

Intervention

Drug:
• AIV001
Intradermal

Locations

Country	Name	City	State
United States	California Dermatology & Clinical Research Institute	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
AiViva BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence of adverse events	Approximately 365 days
Secondary	Keloid recurrence	Number of subjects experiencing keloid recurrence within study duration	365 days