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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halscion, Inc.
ClinicalTrials.gov Identifier:
NCT01446770
First received: October 2, 2011
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Keloid
Device: Hydrogel scaffold (MF-4181)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Comparative Feasibility Study Evaluating the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181 Adjunctive to Surgical Scar Revision

Resource links provided by NLM:


Further study details as provided by Halscion, Inc.:

Primary Outcome Measures:
  • Device safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Device safety is defined as the incidence of device related adverse events.


Secondary Outcome Measures:
  • Device efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.

  • Device efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Volume and linear measurements will be taken by the investigator

  • Device efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.


Enrollment: 19
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Hydrogel scaffold (MF-4181)
    Following surgical removal of the ear keloid, the incision will be treated with MF-4181.
    Other Name: Hydrogel scaffold
  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Known hypersensitivities to animal-based products
  • Previous participation in this study to avoid multiple enrollments of an individual subject.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446770

Locations
Bahamas
Princess Margaret Hospital
Nassau, Bahamas
Sponsors and Collaborators
Halscion, Inc.
Investigators
Principal Investigator: Srikanth Garikaparthi, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: Halscion, Inc.
ClinicalTrials.gov Identifier: NCT01446770     History of Changes
Other Study ID Numbers: HAL-0127
Study First Received: October 2, 2011
Last Updated: March 12, 2012
Health Authority: Government of Bahamas: Ministry of Health

Additional relevant MeSH terms:
Keloid
Cicatrix
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014