Peri-orbital WrinklesNCT01813760
Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser
A study testing Illuiminage ® Diode Laser in people with Peri-orbital Wrinkles and Peri-oral Wrinkles, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Peri-orbital Wrinkles, Peri-oral Wrinkles
- What is being tested?
- Illuiminage ® Diode Laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2013
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who are healthy females between 35 and 60 years of age.
- Subjects who have Fitzpatrick skin type I-VI
- Subjects who have provided written and verbal informed consent
- Subjects who are willing and able to comply with study instructions and to return to the clinic for required visits and have photographs of their face taken
- Subjects who have perioral and periorbital wrinkles, as deemed appropriate by the Investigator or his designees
Who cannot join
- Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mendelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products. on the laser application areas
- Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study,
- Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
- Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas
- Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated
- Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin
Show all 13Show fewer
- Subjects who have participated in any clinical investigation involving the face within the 30 days prior to the first planned laser application or subjects who plan to participate in concomitant facial studies during this trial
- Subjects, who are pregnant, were pregnant or gave birth in the last 3 months, are currently breast feeding, or might become pregnant during the course of the study
- Subjects who have a history of light triggered seizures
- Subjects with prior use of neurotoxins e.g. Botox®, collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) of the face or having had chemical peels within 6 months of initial laser application or planning to so during the course of the study
- Subject's use of oral isotretinoin (Accutane®) within 12 months of initial laser application or during the course of the study
- Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year
- Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia® or Tria®
Trial locations and contacts
1 site in 1 country.
About this study
The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth.
- Conditions
- Peri-orbital Wrinkles, Peri-oral Wrinkles
- Being tested
- Illuiminage ® Diode Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Illuiminage ® Diode LaserDevice
Diode laser for treatment of peri-orbital and peri-oral wrinkles
| Study group | Role | What they receive |
|---|---|---|
| Diode laser | Experimental | Diode laser to treat peri-orbital and peri-oral wrinkles Receives: Device: Illuiminage ® Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluation
Compare severity of wrinkles from baseline to 60 days post treatment based on Fitpatrick Scale.
Measured: 60 days post first treatment
Secondary outcomes (2)
Number of Participants with Adverse Events
Adverse events and side effects will be recorded
Measured: up to 4 months post 1st treatment
Photographic Evaluation
Compare severity of wrinkles from baseline to 1,10, 20 and 40 days post treatment based on Fitzpatrick Scale.
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-orbital WrinklesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Krantz, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813760
- Sponsor's protocol ID
- CYN12-AFF-UL-09
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser
- ClinicalTrials.gov ID
- NCT01813760
- Acronym / sponsor ID
- CYN12-AFF-UL-09
- Conditions
- Peri-orbital Wrinkles, Peri-oral Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Mar 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.
The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diode laser | Experimental | Device: Illuiminage ® Diode LaserDiode laser to treat peri-orbital and peri-oral wrinkles |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who are healthy females between 35 and 60 years of age.
- Subjects who have Fitzpatrick skin type I-VI
- Subjects who have provided written and verbal informed consent
- Subjects who are willing and able to comply with study instructions and to return to the clinic for required visits and have photographs of their face taken
- Subjects who have perioral and periorbital wrinkles, as deemed appropriate by the Investigator or his designees
Key exclusion criteria (13 listed)
- Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mendelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products. on the laser application areas
- Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study,
- Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
- Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas
- Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated
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 |
|---|---|---|
| Illuiminage ® Diode LaserDiode laser for treatment of peri-orbital and peri-oral wrinkles | Device | Diode laser |
Primary outcome
Photographic Evaluation
Time frame: 60 days post first treatment
Compare severity of wrinkles from baseline to 60 days post treatment based on Fitpatrick Scale.
2 secondary outcomes
Number of Participants with Adverse Events
Time frame: up to 4 months post 1st treatment
Photographic Evaluation
Time frame: Up to 40 days
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 26 Mar 2014.
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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.
Patricia Krantz study director
Cynosure, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Illuiminage ® Diode Laser in people with Peri-orbital Wrinkles and Peri-oral Wrinkles, run by Cynosure, Inc. 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 5 inclusion and 13 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 26 Mar 2014. 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?
Photographic Evaluation (time frame: 60 days post first 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 26 Mar 2014.