Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
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|ClinicalTrials.gov Identifier: NCT01446770|
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : March 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Keloid||Device: Hydrogel scaffold (MF-4181)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Device: Hydrogel scaffold (MF-4181)
- Device safety [ Time Frame: 6 months ]Device safety is defined as the incidence of device related adverse events.
- Device efficacy [ Time Frame: 12 months ]Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
- Device efficacy [ Time Frame: 12 months ]Volume and linear measurements will be taken by the investigator
- Device efficacy [ Time Frame: 12 months ]Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446770
|Princess Margaret Hospital|
|Principal Investigator:||Srikanth Garikaparthi, MD||Princess Margaret Hospital, Canada|