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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01446770
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Halscion, Inc.

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.

Condition or disease Intervention/treatment Phase
Keloid Device: Hydrogel scaffold (MF-4181) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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

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

Secondary Outcome Measures :
  1. Device efficacy [ Time Frame: 12 months ]
    Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.

  2. Device efficacy [ Time Frame: 12 months ]
    Volume and linear measurements will be taken by the investigator

  3. Device efficacy [ Time Frame: 12 months ]
    Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446770

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Princess Margaret Hospital
Nassau, Bahamas
Sponsors and Collaborators
Halscion, Inc.
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Principal Investigator: Srikanth Garikaparthi, MD Princess Margaret Hospital, Canada
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Responsible Party: Halscion, Inc. Identifier: NCT01446770    
Other Study ID Numbers: HAL-0127
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Collagen Diseases
Connective Tissue Diseases
Pathologic Processes