Clinical trial NCT02659124: Comparison of AmnioFix Laser and Standard of Care Treatment
Official title: Comparison of AmnioFix Laser and Standard of Care in Patients Seeking Laser Facial Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rhytides
Keywords: facial laser
fraction ablative resurfacing
total ablative resurfacing
EpiFix
rhytides
wrinkles
AmnioFix
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Time of reepithelialization
timeFrame: 28 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Dermatology
state: California
Study officials:
References: