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

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

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

Study Overview

• Status: Completed
• Conditions: Keloid
• Intervention / Treatment: Drug: AIV001

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIV001 Treatment Dose 1; Intradermal, Dose 1	Drug: AIV001; Intradermal
Experimental: AIV001 Treatment Dose 2; Intradermal, Dose 2	Drug: AIV001; Intradermal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence of adverse events	Approximately 365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keloid recurrence	Number of subjects experiencing keloid recurrence within study duration	365 days

Collaborators and Investigators

• Sponsor: AiViva BioPharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Scar formation; Keloidectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Recurrence; Keloid
• Other Study ID Numbers: AIV001-W02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No