Facial RejuvenationNCT02107157
Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation
A study testing 755nm Laser with Cap Array in people with Facial Rejuvenation, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a Lens Array for the 755nm Alexandrite laser. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facial Rejuvenation
- What is being tested?
- 755nm Laser with Cap Array
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a healthy male or female between 18 and 65 years old
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
Who cannot join
- The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- The subject has active or localized systemic infections.
- The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
Show all 14Show fewer
- The subject has used Accutane within 6 months prior to enrollment.
- The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- The subject has a history of keloids.
- The subject has evidence of compromised wound healing.
- The subject has a history of squamous cell carcinoma or melanoma.
- The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- The subject has an allergy to lidocaine and epinephrine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology and Laser Surgery
Sacramento, California, 95819
About this study
The purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a Lens Array for the 755nm Alexandrite laser.
- Conditions
- Facial Rejuvenation
- Being tested
- 755nm Laser with Cap Array
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
755nm Laser with Cap ArrayDevice
| Study group | Role | What they receive |
|---|---|---|
| 755nm Alexandrite laser with cap array | Experimental | Not described Receives: Device: 755nm Laser with Cap Array |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Facial Scarring Score
Physicians will examine the subjects' facial scarring using the Physician Global Scarring Grading (PGSG) scale. This scale counts and types scars by tallying up of the number and severity of the scars according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Measured: Baseline and 3 months post last treatment
Photodamage Score Change
The photodamage is assessed by examining fine wrinkles, mottled hyperpigmentation, and overall integrated assessment of photodamage. These 3 categories are broken down into their own scales of 0 to 4 based on severity. 0 indicates none, 1 indicates minimal, 2 indicates mild, 3 indicates moderate, and 4 indicates severe. The total points from all 3 categories added up will range from 0 to 12, where 12 is the most photodamage possible. A decrease in score indicates less photodamage.
Measured: Baseline and 3 months post last treatment
Number of Participants With Signs of New Collagen Generations
Subjects will have one 3mm punch biopsy obtained pretreatment from an inconspicuous area and subsequent biopsies at one or any of the following visits after treatment. Pathologies will be provided by pathologists who are able to determine any developments of dermal mucus, dermal elastic fibers, or changes in collagen III. An increase in any of these categories corresponds with skin rejuvenation.
Measured: 3 months post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial RejuvenationStudies 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
- 27 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
- NCT02107157
- Sponsor's protocol ID
- CYN13-PICO-CAPHST-ET
- Status last verified
- Jan 2021
- First submitted
- 31 Mar 2014
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
PubMed 31896400
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT02107157
- Acronym / sponsor ID
- CYN13-PICO-CAPHST-ET
- Conditions
- Facial Rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a Lens Array for the 755nm Alexandrite laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 755nm Alexandrite laser with cap array | Experimental | Device: 755nm Laser with Cap Array |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is a healthy male or female between 18 and 65 years old
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
Key exclusion criteria (14 listed)
- The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- The subject has active or localized systemic infections.
- The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
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 |
|---|---|---|
| 755nm Laser with Cap Array | Device | 755nm Alexandrite laser with cap array |
Primary outcome
Changes in Facial Scarring Score
Time frame: Baseline and 3 months post last treatment
Physicians will examine the subjects' facial scarring using the Physician Global Scarring Grading (PGSG) scale. This scale counts and types scars by tallying up of the number and severity of the scars according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Photodamage Score Change
Time frame: Baseline and 3 months post last treatment
The photodamage is assessed by examining fine wrinkles, mottled hyperpigmentation, and overall integrated assessment of photodamage. These 3 categories are broken down into their own scales of 0 to 4 based on severity. 0 indicates none, 1 indicates minimal, 2 indicates mild, 3 indicates moderate, and 4 indicates severe. The total points from all 3 categories added up will range from 0 to 12, where 12 is the most photodamage possible. A decrease in score indicates less photodamage.
Number of Participants With Signs of New Collagen Generations
Time frame: 3 months post last treatment
Subjects will have one 3mm punch biopsy obtained pretreatment from an inconspicuous area and subsequent biopsies at one or any of the following visits after treatment. Pathologies will be provided by pathologists who are able to determine any developments of dermal mucus, dermal elastic fibers, or changes in collagen III. An increase in any of these categories corresponds with skin rejuvenation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31896400Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
- This is an explanation of the Fitzpatrick Skin typing that is described in the baseline characteristics section.Link provided by the sponsor.
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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 755nm Laser with Cap Array in people with Facial Rejuvenation, 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 3 inclusion and 14 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 20 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Facial Scarring Score (time frame: Baseline and 3 months post last treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02107157, which also lists 1 linked publication.
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 20 Jan 2021.