Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181

NCT01446770 | Completed Phase 2

• 1 other identifier: HAL-0127
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• Device safety

  Device safety is defined as the incidence of device related adverse events.

  6 months

Secondary Outcomes (3)

• Device efficacy

  12 months

• Device efficacy

  12 months

• Device efficacy

  12 months

Interventions

Hydrogel scaffold (MF-4181) DEVICE

Following surgical removal of the ear keloid, the incision will be treated with MF-4181.

Also known as: Hydrogel scaffold

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subjects 15 to 50 years of age each having at least one keloid scar on the ear. (If both ears have keloids, both ears may be treated with E-Matrix).
• Keloids that have not undergone more than two surgical revisions (laser, cryotherapy or surgery)
• Keloids that have been present for ≥ 1 year.
• The keloid must measure ≥ 0.5 cm and not extend onto other portions of the head, neck, or face.
• Able and willing to give written informed consent. (Age 15-17 must have written informed consent of legal guardian).
• Willing to comply with the follow up schedule for a minimum of 6 months.

You may not qualify if:

• Subjects with history of prior treatment at the study site or prior treatment of the keloid in the previous 6 weeks.
• Pregnant or planning to become pregnant during the course of the study.
• Heart disease or history of congestive heart failure.
• Advanced or poorly controlled diabetes.
• Current or history of heavy smoking (i.e., 10 pack years)
• Active local infection at the treatment site and/or systemic infection.
• History of or active central nervous system disease.
• History of fever, migraine headaches, and/or recurrent upper respiratory infection.
• Active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura.
• Unwilling or unable to return for follow-up visits.
• Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study, including steroid injections.
• Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated.
• Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic.
• Unable or unwilling to follow post-operative instructions.
• Known hypersensitivity to MF-4181, collagen, dextran, or any of its constituent materials.

Sponsors & Collaborators

• Halscion, Inc.: lead

Study Sites (1)

Princess Margaret Hospital

Nassau, The Bahamas

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Srikanth Garikaparthi, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2011
• First Posted: October 5, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

TH (1)