Comparison of AmnioFix Laser and Standard of Care Treatment

NCT ID: NCT02659124

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2018-01-31

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

Conditions

Rhytides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

AmnioFix plus Standard of Care

Intervention Type: DEVICE

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.

Standard of Care

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Dermatology

San Francisco, California, United States

Countries

United States

Other Identifiers

AmnioFix Laser Study

Identifier Type: -

Identifier Source: org_study_id