Comparison of AmnioFix Laser and Standard of Care Treatment

NCT02659124 | Withdrawn

• 1 other identifier: AmnioFix Laser Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhytides

Keywords

facial laser; fraction ablative resurfacing; total ablative resurfacing; EpiFix; rhytides; wrinkles; AmnioFix

Outcome Measures

Primary Outcomes (1)

• Time of reepithelialization

  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.

  28 days after treatment

Study Arms (1)

Standard of Care plus AmnioFix

OTHER

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; Procedure: Standard of Care

Interventions

AmnioFix plus Standard of Care 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 plus AmnioFix

Standard of Care 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.

Standard of Care plus AmnioFix

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients ages 18-100 seeking laser facial treatment

You may not qualify if:

• patients with treatment areas with active or latent infection
• patient with a disorder that would create an unacceptable risk of post-operative complications

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Dermatology

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 20, 2016
• Primary Completion: April 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)