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A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
This study is ongoing, but not recruiting participants.
First Received: December 21, 2007   Last Updated: March 2, 2009   History of Changes
Sponsored by: Organogenesis
Information provided by: Organogenesis
ClinicalTrials.gov Identifier: NCT00587587
  Purpose

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.


Condition Intervention Phase
Keloid
Device: Apligraf
Other: Standard dressing regimen
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

Further study details as provided by Organogenesis:

Primary Outcome Measures:
  • The primary purpose of this study will be to gain preliminary safety experience with Apligraf in the keloid indication [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in keloid recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Cumulative incidence of recurrence at Wk 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Degree of recurrence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Physician global assessment and subject assessment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Decreased utilization of intralesional steroid intervention [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2007
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Apligraf (bilayered living cell therapy)
Device: Apligraf
Application at Day 0, potential re-application at Week 4
B: Active Comparator
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
Other: Standard dressing regimen
A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587587

Locations
United States, Florida
University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
Miami Beach, Florida, United States, 33140
Sponsors and Collaborators
Organogenesis
Investigators
Principal Investigator: Heather Woolery-Lloyd, MD University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
Study Director: Damien Bates, MD, PhD, FRACS (Plast.) Organogenesis Inc.
  More Information

No publications provided

Responsible Party: Organogenesis Inc. ( Katherine B. Giovino, Director of Clinical Operations )
Study ID Numbers: 06-KEL-001-AG
Study First Received: December 21, 2007
Last Updated: March 2, 2009
ClinicalTrials.gov Identifier: NCT00587587     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Skin Diseases
Collagen Diseases
Keloid
Connective Tissue Diseases
Recurrence
Cicatrix

Additional relevant MeSH terms:
Skin Diseases
Collagen Diseases
Keloid
Connective Tissue Diseases
Cicatrix

ClinicalTrials.gov processed this record on July 02, 2009