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

• Sponsor: AiViva BioPharma, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04827875
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Keloid	Drug: AIV001	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jun 23, 2021
• Anticipated Primary Completion Date: Jul 10, 2023
• Anticipated Study Completion Date: Oct 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse events [Approximately 365 days]

   Incidence of adverse events

Secondary Outcome Measures

1. Keloid recurrence [365 days]

   Number of subjects experiencing keloid recurrence within study duration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Dermatology & Clinical Research Institute	Encinitas	California	United States	92024

Sponsors and Collaborators

• AiViva BioPharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AiViva BioPharma, Inc.
• ClinicalTrials.gov Identifier: NCT04827875
• Other Study ID Numbers: AIV001-W02
• First Posted: Apr 1, 2021
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AiViva BioPharma, Inc.: Scar formation; Keloidectomy
• Additional relevant MeSH terms: Keloid; Recurrence

Study Results

No Results Posted as of May 13, 2022