Comparison of AmnioFix Laser and Standard of Care Treatment

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02659124

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhytides	Device: AmnioFix plus Standard of Care Procedure: Standard of Care	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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

Anticipated Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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