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

NCT04827875 | Completed Phase 1 FDA Drug

• 1 other identifier: AIV001-W02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the saftye and effectiveness of AIV001 treatment on scar formation and/or keloid scar recurrence following keloidectomy.

Conditions

Keloid; Scar; Incision; Excision Margin

Keywords

Scar formation; Keloidectomy

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence of adverse events

  Approximately 365 days

Secondary Outcomes (2)

• Keloid recurrence

  365 days

• Modified Vancouver Scar Scale (mVSS)

  Day 90 and Day 180

Study Arms (2)

AIV001 Treatment Dose 1

EXPERIMENTAL

Intradermal, Dose 1

Drug: AIV001

AIV001 Treatment Dose 2

EXPERIMENTAL

Intradermal, Dose 2

Drug: AIV001

Interventions

AIV001 DRUG

Intradermal

AIV001 Treatment Dose 1; AIV001 Treatment Dose 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AiViva BioPharma, Inc.: lead

Study Sites (4)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146, United States

Location

DermResearch DRI

Austin, Texas, 78759, United States

Location

J&S Studies

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Keloid; Cicatrix; Surgical Wound; Margins of Excision

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Morphological and Microscopic Findings

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Excisions of existing keloid scar, treatment of incisional area followed by evaluation of scar formation overtime.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: June 23, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (4)