Clinical trial NCT00587587: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Keloid
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2008-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)
timeFrame: Baseline to Week 52 or Last Visit
measure: Cumulative Incidence of Keloid Recurrence at Week 52
timeFrame: 52 weeks
measure: Degree of Recurrence (Scar Firmness)
timeFrame: Week 52 or Last Visit
measure: Degree of Recurrence (Scar Thickness)
timeFrame: Week 52 or Last visit
measure: Physician Global Assessment
timeFrame: Week 52 or Last Visit
measure: Subject Global Assessment
timeFrame: Week 52 or Last Visit
measure: Decreased Utilization of Intralesional Steroid Intervention
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
state: Florida
Study officials:
affiliation: University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
name: Heather Woolery-Lloyd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Organogenesis Inc.
name: Damien Bates, MD, PhD, FRACS (Plast.)
role: STUDY_DIRECTOR
References: