Back to resultsEvaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
Primary Purpose
Keloid
Status
Completed
Phase
Phase 2
Locations
Bahamas
Study Type
Interventional
Intervention
Hydrogel scaffold (MF-4181)
Sponsored by
About this trial
This is an interventional treatment trial for Keloid
Eligibility 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.
Sites / Locations
- Princess Margaret Hospital
Outcomes
Primary Outcome Measures
Device safety
Device safety is defined as the incidence of device related adverse events.
Secondary Outcome Measures
Device efficacy
Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
Device efficacy
Volume and linear measurements will be taken by the investigator
Device efficacy
Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01446770
Brief Title
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Halscion, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Hydrogel scaffold (MF-4181)
Other Intervention Name(s)
Hydrogel scaffold
Intervention Description
Following surgical removal of the ear keloid, the incision will be treated with MF-4181.
Primary Outcome Measure Information:
Title
Device safety
Description
Device safety is defined as the incidence of device related adverse events.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Device efficacy
Description
Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
Time Frame
12 months
Title
Device efficacy
Description
Volume and linear measurements will be taken by the investigator
Time Frame
12 months
Title
Device efficacy
Description
Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srikanth Garikaparthi, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Nassau
Country
Bahamas
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
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