Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT02659124 |
Other study ID # |
AmnioFix Laser Study |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Est. completion date |
January 2018 |
Study information
Verified date |
March 2022 |
Source |
University of California, San Francisco |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is a comparison trial with novel application of AmnioFix and a control arm. Patients
electively being treated with facial lasers will be assigned to receive AmnioFix in addition
to the normal standard of care placed on half of their face after laser procedure, and normal
post laser standard of care alone on the other half of their face. The investigators will
investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic
factors. The study is designed to compare AmnioFix to the current standard of laser care.
Description:
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