A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
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.
Other: Standard dressing regimen
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids|
- 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. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Summary of all reported adverse events (AE) in the intent to treat (ITT) population.
AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
- Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS) [ Time Frame: Baseline to Week 52 or Last Visit ] [ Designated as safety issue: No ]
Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.
BSS is a composite score where the individual scores from the following categories are summed:
Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).
Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar).
- Cumulative Incidence of Keloid Recurrence at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.
- Degree of Recurrence (Scar Firmness) [ Time Frame: Week 52 or Last Visit ] [ Designated as safety issue: No ]Scar firmness measured by Cutometer in millimeters.
- Degree of Recurrence (Scar Thickness) [ Time Frame: Week 52 or Last visit ] [ Designated as safety issue: No ]Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.
- Physician Global Assessment [ Time Frame: Week 52 or Last Visit ] [ Designated as safety issue: No ]Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
- Subject Global Assessment [ Time Frame: Week 52 or Last Visit ] [ Designated as safety issue: No ]Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
- Decreased Utilization of Intralesional Steroid Intervention [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.
|Study Start Date:||December 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Apligraf (bilayered living cell therapy)
Application at Day 0, potential re-application at Week 4
Active Comparator: B
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
|United States, Florida|
|University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology|
|Miami Beach, Florida, United States, 33140|
|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.|