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

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