Rhytides
Conditions
Keywords
facial laser, fraction ablative resurfacing, total ablative resurfacing, EpiFix, rhytides, wrinkles, AmnioFix
Brief 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.
Detailed 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
Interventions
DEVICEAmnioFix 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.
PROCEDUREStandard 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.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* adult patients ages 18-100 seeking laser facial treatment
Exclusion criteria
* patients with treatment areas with active or latent infection * patient with a disorder that would create an unacceptable risk of post-operative complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of reepithelialization | 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. |
Countries
United States
Outcome results
None listed