Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Comparative Feasibility Study Evaluating the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181 Adjunctive to Surgical Scar Revision|
- Device safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Device safety is defined as the incidence of device related adverse events.
- Device efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
- Device efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]Volume and linear measurements will be taken by the investigator
- Device efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
|Study Start Date:||November 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Device: Hydrogel scaffold (MF-4181)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446770
|Princess Margaret Hospital|
|Principal Investigator:||Srikanth Garikaparthi, MD||Princess Margaret Hospital, Canada|