Comparison of AmnioFix Laser and Standard of Care Treatment
|ClinicalTrials.gov Identifier: NCT02659124|
Recruitment Status : Withdrawn (The current protocol did not satisfy IRB requirements)
First Posted : January 20, 2016
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rhytides||Device: AmnioFix plus Standard of Care Procedure: Standard of Care||Not Applicable|
AmnioFix is a dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. Amniotic membrane is a unique material and its composition contains collagen types I, III, IV, V, and VII. Amniotic membrane is composed of structural extracellular matrix (ECM), that also contains specialized proteins fibronectin, laminins, proteoglycans and glycosaminoglycans. In addition, amniotic membrane contains essential, active, healing growth factors such as epidermal growth factor (EGF), transforming growth factor beta (TGF-b), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF).
The study is designed to compare AmnioFix to the current standard of laser care.
- Patients coming in for fraction or total ablative resurfacing with any methods will be studied
- patients will be assessed prior to any treatment by clinician
- additionally patients will participate in a clinician constructed survey
- patients will be assessed on a rating scale of 1-4 based on erythema, edema/induration, oozing/drainage, and epithelialization
- preoperative photos will be taken of patients
- laser resurfacing will proceed under clinician guidance, and under clinician selected settings
- repeat photographs
- patients will be randomized as to which side of the face receives AmnioFix treatment, and which side receives standard of care
- epifix will be applied appropriatly
- repeat photographs and repeat assessment on 1-4 scale
- patients will follow up at day 1, 4, 7, 14, and 28 +/-3 days to repeat scoring and photography
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of AmnioFix Laser and Standard of Care in Patients Seeking Laser Facial Treatment|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||January 2018|
Standard of Care plus AmnioFix
All patients will receive the standard of care alone on half of their face, and AmnioFix in addition to the standard of care on the other half of their face.
Device: AmnioFix plus Standard of Care
Patients will receive the standard of care alone on half of their face, and AmnioFix in addition to the standard of care on the other half of their face. The standard of care after ablative resurfacing is conservative wound care which may include flexible wound care dressings and/or emollients.
Procedure: Standard of Care
Patients will receive the standard of care dressing only, on their face. The standard of care after ablative resurfacing is conservative wound care which may include flexible wound care dressings and/or emollients.
- Time of reepithelialization [ Time Frame: 28 days after treatment ]Subjects' healing and recovery is the primary outcome measure. Reepithelialization will be assessed at each follow up visit, considering the following: erythema, edema/induration, and oozing/drainage.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659124
|United States, California|
|San Francisco, California, United States, 94115|