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Comparison of AmnioFix Laser and Standard of Care Treatment

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ClinicalTrials.gov Identifier: NCT02659124
Recruitment Status : Withdrawn (The current protocol did not satisfy IRB requirements)
First Posted : January 20, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Sarah Arron, University of California, San Francisco

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : January 2018
Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Time of reepithelialization [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659124


Locations
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United States, California
UCSF Dermatology
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
More Information
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Responsible Party: Sarah Arron, Sarah Arron, MD, PhD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02659124    
Other Study ID Numbers: AmnioFix Laser Study
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sarah Arron, University of California, San Francisco:
facial laser
fraction ablative resurfacing
total ablative resurfacing
EpiFix
 rhytides
wrinkles
AmnioFix