Condition(s) treated: Keloid

Intervention: Apligraf (Device); Standard dressing regimen (Other)

Phase: Phase 1/Phase 2

Enrollment status: Recruiting

Sponsor: Organogenesis

Principal investigator(s) or official(s):
Heather Woolery-Lloyd, MD, Principal Investigator, Affiliation: University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
Damien Bates, MD, PhD, FRACS (Plast.), Study Director, Affiliation: Organogenesis Inc.

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.

Official title: A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

Study design: Treatment, Randomized, Open Label, Parallel Assignment

Primary outcome: The primary purpose of this study will be to gain preliminary safety experience with Apligraf in the keloid indication (Time Frame: 52 weeks)

Secondary outcome:
Reduction in keloid recurrence (Time Frame: 52 weeks)

Cumulative incidence of recurrence at Wk 52. (Time Frame: 52 weeks)

Degree of recurrence (Time Frame: 52 weeks)

Physician global assessment and subject assessment (Time Frame: 52 weeks)

Decreased utilization of intralesional steroid intervention (Time Frame: 52 weeks)

Minimum eligible age: 18 Years. Maximum eligible age: 65 Years. Eligible gender(s): Both.

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

University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology, Miami Beach, Florida 33140, United States; Recruiting
Laura Black, Phone: 305-531-5788, Email: lblack@med.miami.edu
Heather Woolery-Lloyd, MD, Principal Investigator

Start date: December 2007
End date: March 2009
Last updated: March 31, 2008

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