A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

NCT ID: NCT00587587

Last Updated: 2011-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-03-31

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.

Conditions

Keloid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Apligraf (bilayered living cell therapy)

Group Type: EXPERIMENTAL

Apligraf

Intervention Type: DEVICE

Application at Day 0, potential re-application at Week 4

B

Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary

Group Type: ACTIVE_COMPARATOR

Standard dressing regimen

Intervention Type: OTHER

A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary

Interventions

Apligraf

Application at Day 0, potential re-application at Week 4

Intervention Type: DEVICE

Standard dressing regimen

A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organogenesis

INDUSTRY

Sponsor Role: lead

Responsible Party

Organogenesis Inc.

Principal Investigators

Heather Woolery-Lloyd, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology

Damien Bates, MD, PhD, FRACS (Plast.)

Role: STUDY_DIRECTOR

Organogenesis Inc.

Locations

University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology

Miami Beach, Florida, United States

Countries

United States

Other Identifiers

06-KEL-001-AG

Identifier Type: -

Identifier Source: org_study_id