Facial AgingNCT01986634
Laser Spot Treatment of Perioral Rhytids
A study testing Laser Treatment in people with Facial Aging, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing, usually with laser treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Facial Aging
- What is being tested?
- Laser Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 31 Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who are electively presenting to the plastic surgery department for evaluation and treatment of facial aging and elect/seek to have laser treatment will be asked to voluntarily participate in the study.
- Fitzpatrick type 1-4 skin
Who cannot join
- 1 Patients undergoing additional invasive cosmetic procedure at the same time including rhytidectomy, fat injection
- 2 History of Photosensitvity
- 3 Use of photosenstive medications
- 4 History of keloid or hypertrophic scarring
- 5 Use of Isotretinoin in the previous year
- 6 Previous resurfacing procedure (laser or chemical peel) within the previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy Hospitals Cedar Brainard Office
Lyndhurst, Ohio, 44124
About this study
Official title: Efficacy of Spot Treatment of Perioral Rhytids Compared to Full Field Laser Resurfacing
Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing, usually with laser treatment. Often the peri-oral area is treated with additional spot treatments with an ablative laser to cause a more robust healing response and better aesthtic result. To date, no studies have specifically shown efficacy of additional spot treatment over full facial laser alone.
This study is designed as a split-face study, to compare the aesthetic results of full field laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on the other half.
To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is used by many surgeons/laser proceduralists for addressing specific areas of the face. This is an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and enviromental factors that can effect the results the best design for the study to is have each patient serve as their own control with a split-face study.
Read the detailed description
Cohort Study, with Split Face treatment
Methods:
Patients will be evaluated in the office for possible inclusion. Those who agree to partipate will receive preoperative photos.
On the day of the procedure patients will have a topical anesthestic applied for 30 minutes, then patients will recieve a 20um laser resurfacing of the entire face to remove dead skin and debris. After that, patients will have reapplication of a topical anesthetic for an additional 10 minutes. They will then undergo a 50 um peel to one side of the face and a patient tailored spot treatment of perioral wrinkles to the other side of the face. The depth of this may vary from 100 to 400um.
Patients will return to clinic at 1 week, 2 weeks, and 3 weeks post-procedure and fill out a short survey and have medical photography done. Patients will return at 3 and 6 month follow-up for additional photography and surveys. These visits will typically take 10 to 20 minutes.
Preoperative and post-operative photos will be analyzed by 2 independent plastic surgeons for post-operative changes and improvements.
- Conditions
- Facial Aging
- Being tested
- Laser Treatment
- Keywords
- Laser Resurfacing, Rhytids, Perioral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TreatmentProcedure or surgery
Patient will have split face laser resurfacing as per standard of care. One side of the face will be treated with a standardized single depth laser peel. The other side of the perioral area will be treated with variant, deeper treatment to perioral rhytids.
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Other | Patients enrolled will have split face laser treatment. Patients will serve as their own control. Receives: Procedure: Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in perioral rhytids
at 3 and 6 month post-operative visits, photographs will be taken and analyzed for improvement in rhytids.
Measured: 3-6 months
Secondary outcomes (1)
Time to healing after laser resurfacing
Each side of the face will be assessed for time to healing.
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startSep 2013
- Primary completion31 Aug 2014
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AgingStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Rowe, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986634
- Sponsor's protocol ID
- 01-13-12
- Status last verified
- Jun 2023
- First submitted
- 11 Nov 2013
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Spot Treatment of Perioral Rhytids Compared to Full Field Laser Resurfacing
- ClinicalTrials.gov ID
- NCT01986634
- Acronym / sponsor ID
- 01-13-12
- Conditions
- Facial Aging
- Keywords
- Laser Resurfacing, Rhytids, Perioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 18 Nov 2013 (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.
Perioral rhytides present a difficult problem in facial rejuvenation. They cannot be addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable scars. Currently, fine static wrinkles are most effectively treated with facial resurfacing, usually with laser treatment. Often the peri-oral area is treated with additional spot treatments with an ablative laser to cause a more robust healing response and better aesthtic result. To date, no studies have specifically shown efficacy of additional spot treatment over full facial laser alone.
This study is designed as a split-face study, to compare the aesthetic results of full field laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on the other half.
To clarify further to the IRB board, this is not an experimental treatment. Spot treatment is used by many surgeons/laser proceduralists for addressing specific areas of the face. This is an FDA indicated use of the laser for facial resurfacing. Due to the many genetic and enviromental factors that can effect the results the best design for the study to is have each patient serve as their own control with a split-face study.
Detailed description
Cohort Study, with Split Face treatment
Methods:
Patients will be evaluated in the office for possible inclusion. Those who agree to partipate will receive preoperative photos.
On the day of the procedure patients will have a topical anesthestic applied for 30 minutes, then patients will recieve a 20um laser resurfacing of the entire face to remove dead skin and debris. After that, patients will have reapplication of a topical anesthetic for an additional 10 minutes. They will then undergo a 50 um peel to one side of the face and a patient tailored spot treatment of perioral wrinkles to the other side of the face. The depth of this may vary from 100 to 400um.
Patients will return to clinic at 1 week, 2 weeks, and 3 weeks post-procedure and fill out a short survey and have medical photography done. Patients will return at 3 and 6 month follow-up for additional photography and surveys. These visits will typically take 10 to 20 minutes.
Preoperative and post-operative photos will be analyzed by 2 independent plastic surgeons for post-operative changes and improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Other | Procedure: Laser TreatmentPatients enrolled will have split face laser treatment. Patients will serve as their own control. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who are electively presenting to the plastic surgery department for evaluation and treatment of facial aging and elect/seek to have laser treatment will be asked to voluntarily participate in the study.
- Fitzpatrick type 1-4 skin
Key exclusion criteria (6 listed)
- 1 Patients undergoing additional invasive cosmetic procedure at the same time including rhytidectomy, fat injection
- 2 History of Photosensitvity
- 3 Use of photosenstive medications
- 4 History of keloid or hypertrophic scarring
- 5 Use of Isotretinoin in the previous year
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 |
|---|---|---|
| Laser TreatmentPatient will have split face laser resurfacing as per standard of care. One side of the face will be treated with a standardized single depth laser peel. The other side of the perioral area will be treated with variant, deeper treatment to perioral rhytids. | Procedure or surgery | Laser Treatment |
Primary outcome
Improvement in perioral rhytids
Time frame: 3-6 months
at 3 and 6 month post-operative visits, photographs will be taken and analyzed for improvement in rhytids.
1 secondary outcome
Time to healing after laser resurfacing
Time frame: 2-3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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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.
David J Rowe, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Treatment in people with Facial Aging, run by University Hospitals Cleveland Medical Center 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jul 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in perioral rhytids (time frame: 3-6 months). 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 5 Jul 2023.