NCT02659124

Comparison of AmnioFix Laser and Standard of Care Treatment

Comparison of AmnioFix Laser and Standard of Care in Patients Seeking Laser Facial Treatment

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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

Conditions

• Rhytides

Interventions

Type	Name	Description
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.

Timeline

• Primary completion: 2017-04-01
• Completion: 2018-01-01
• First posted: 2016-01-20
• Last updated: 2022-03-21

Locations

1 site across 1 country: United States