RhytidesNCT02659124
Comparison of AmnioFix Laser and Standard of Care Treatment
A study of Rhytides, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhytides
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients ages 18-100 seeking laser facial treatment
Who cannot join
- patients with treatment areas with active or latent infection
- patient with a disorder that would create an unacceptable risk of post-operative complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of AmnioFix Laser and Standard of Care in Patients Seeking Laser Facial Treatment
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.
Read the 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
- Being tested
- AmnioFix plus Standard of Care, Standard of Care
- Keywords
- facial laser, fraction ablative resurfacing, total ablative resurfacing, EpiFix, rhytides, wrinkles, AmnioFix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioFix plus Standard of CareDevice
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 CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AmnioFix plus Standard of Care; Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Primary completionApr 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: The current protocol did not satisfy IRB requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659124
- Sponsor's protocol ID
- AmnioFix Laser Study
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2016
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of AmnioFix Laser and Standard of Care in Patients Seeking Laser Facial Treatment
- ClinicalTrials.gov ID
- NCT02659124
- Acronym / sponsor ID
- AmnioFix Laser Study
- Conditions
- Rhytides
- Keywords
- facial laser, fraction ablative resurfacing, total ablative resurfacing, EpiFix, rhytides, wrinkles, AmnioFix
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The current protocol did not satisfy IRB requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care plus AmnioFix | Other | Device: AmnioFix plus Standard of Care, Procedure: Standard of CareAll 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients ages 18-100 seeking laser facial treatment
Key exclusion criteria (2 listed)
- patients with treatment areas with active or latent infection
- patient with a disorder that would create an unacceptable risk of post-operative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmnioFix plus Standard of CarePatients 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. | Device | Standard of Care plus AmnioFix |
| Standard of CarePatients 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. | Procedure or surgery | Standard of Care plus AmnioFix |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Rhytides, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of reepithelialization (time frame: 28 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.