Back to resultsA Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
Primary Purpose
Keloid
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Apligraf
Standard dressing regimen
Sponsored by
About this trial
This is an interventional treatment trial for Keloid
Eligibility Criteria
Inclusion Criteria:
- Subject is between 18 and 65 years of age.
- Subject or legal guardian has read, understood, and signed appropriate Institutional Review Board (IRB) approved informed consent, photography release form and HIPAA consent in their own language.
- Subject with 1 keloid measuring between 1 cm2 - 40 cm2 as assessed by the Investigator, present for at least 6 months and a Beausang Scar scale combined score of 5 or greater.
- Subject is a male or female who must have a documented negative urine pregnancy test if of child bearing potential. Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
- Subject and/or legal guardian must be able and willing to follow study procedures and instructions.
- Subject and/or legal guardian must be able and willing to return for follow-up study visits.
- Subject agrees to not use a keloid medication or injection treatment for four weeks prior to Day 0.
- Subject agrees not to use any other keloid treatments for the duration of the study.
- Subject is otherwise healthy as assessed and determined by the Investigator
Exclusion Criteria:
- Subject is suffering from a condition likely to require medical attention, including administration of any treatment which in the opinion of the Investigator could influence the results of the study.
- Subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated hemoglobin, HbA1C > 10%), cancer (biopsy confirming active malignancy), positive HIV test, or any disorder(s) that may compromise wound healing.
- Subject is suffering from an abnormal skin condition on the affected area not usually associated with keloids such as psoriasis, or eczema.
- Subject who is currently or has received topical or systemic steroid medication therapy within the past four weeks affecting the course of the keloid and/or its evaluability. Inhaled steroid therapy is acceptable.
- Subject with the presence of acute infections in the areas intended for treatment.
- Subject with known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
- Subject who is lactating or pregnant (positive result as determined by urine testing).
- Subject with liver (ALT/SGPT, ALP, AST/SGOT, bilirubin, albumin, total protein, LDH) and/or renal function (BUN and creatinine) tests > 2 x upper limit of normal (ULN).
- Subject who has been previously enrolled in any wound or investigational device study for any disease within the past four weeks.
- Subject who has received an investigational drug or biological treatment within the past three months.
- Subject previously treated with Apligraf, Dermagraft or any other cell therapy at the target keloid site.
- Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes.
- Subject with a history of anaphylaxis.
- Subject who, in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol
Sites / Locations
- University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Apligraf (bilayered living cell therapy)
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
Outcomes
Primary Outcome Measures
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Summary of all reported adverse events (AE) in the intent to treat (ITT) population.
AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
Secondary Outcome Measures
Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)
Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.
BSS is a composite score where the individual scores from the following categories are summed:
Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).
Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar).
Cumulative Incidence of Keloid Recurrence at Week 52
Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.
Degree of Recurrence (Scar Firmness)
Scar firmness measured by Cutometer in millimeters.
Degree of Recurrence (Scar Thickness)
Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.
Physician Global Assessment
Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Subject Global Assessment
Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Decreased Utilization of Intralesional Steroid Intervention
The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00587587
Brief Title
A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
Official Title
A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Organogenesis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will assess the safety and efficacy of Apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids.
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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Apligraf (bilayered living cell therapy)
Arm Title
B
Arm Type
Active Comparator
Arm Description
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
Intervention Type
Device
Intervention Name(s)
Apligraf
Intervention Description
Application at Day 0, potential re-application at Week 4
Intervention Type
Other
Intervention Name(s)
Standard dressing regimen
Intervention Description
A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary
Primary Outcome Measure Information:
Title
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Description
Summary of all reported adverse events (AE) in the intent to treat (ITT) population.
AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)
Description
Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.
BSS is a composite score where the individual scores from the following categories are summed:
Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).
Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar).
Time Frame
Baseline to Week 52 or Last Visit
Title
Cumulative Incidence of Keloid Recurrence at Week 52
Description
Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.
Time Frame
52 weeks
Title
Degree of Recurrence (Scar Firmness)
Description
Scar firmness measured by Cutometer in millimeters.
Time Frame
Week 52 or Last Visit
Title
Degree of Recurrence (Scar Thickness)
Description
Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.
Time Frame
Week 52 or Last visit
Title
Physician Global Assessment
Description
Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Time Frame
Week 52 or Last Visit
Title
Subject Global Assessment
Description
Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Time Frame
Week 52 or Last Visit
Title
Decreased Utilization of Intralesional Steroid Intervention
Description
The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is between 18 and 65 years of age.
Subject or legal guardian has read, understood, and signed appropriate Institutional Review Board (IRB) approved informed consent, photography release form and HIPAA consent in their own language.
Subject with 1 keloid measuring between 1 cm2 - 40 cm2 as assessed by the Investigator, present for at least 6 months and a Beausang Scar scale combined score of 5 or greater.
Subject is a male or female who must have a documented negative urine pregnancy test if of child bearing potential. Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
Subject and/or legal guardian must be able and willing to follow study procedures and instructions.
Subject and/or legal guardian must be able and willing to return for follow-up study visits.
Subject agrees to not use a keloid medication or injection treatment for four weeks prior to Day 0.
Subject agrees not to use any other keloid treatments for the duration of the study.
Subject is otherwise healthy as assessed and determined by the Investigator
Exclusion Criteria:
Subject is suffering from a condition likely to require medical attention, including administration of any treatment which in the opinion of the Investigator could influence the results of the study.
Subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated hemoglobin, HbA1C > 10%), cancer (biopsy confirming active malignancy), positive HIV test, or any disorder(s) that may compromise wound healing.
Subject is suffering from an abnormal skin condition on the affected area not usually associated with keloids such as psoriasis, or eczema.
Subject who is currently or has received topical or systemic steroid medication therapy within the past four weeks affecting the course of the keloid and/or its evaluability. Inhaled steroid therapy is acceptable.
Subject with the presence of acute infections in the areas intended for treatment.
Subject with known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
Subject who is lactating or pregnant (positive result as determined by urine testing).
Subject with liver (ALT/SGPT, ALP, AST/SGOT, bilirubin, albumin, total protein, LDH) and/or renal function (BUN and creatinine) tests > 2 x upper limit of normal (ULN).
Subject who has been previously enrolled in any wound or investigational device study for any disease within the past four weeks.
Subject who has received an investigational drug or biological treatment within the past three months.
Subject previously treated with Apligraf, Dermagraft or any other cell therapy at the target keloid site.
Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes.
Subject with a history of anaphylaxis.
Subject who, in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Woolery-Lloyd, MD
Organizational Affiliation
University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Damien Bates, MD, PhD, FRACS (Plast.)
Organizational Affiliation
Organogenesis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
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