WrinklesNCT02091102
Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
A study testing 755nm Alexandrite Laser in people with Wrinkles, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using a 755nm Alexandrite Laser. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wrinkles
- What is being tested?
- 755nm Alexandrite Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2014
- 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 non-smoking (must have quit 6 months prior) 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 Retin A or 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 or has an autoimmune disorder.
- The subject has an allergy to lidocaine and epinephrine.
Trial locations and contacts
1 site in 1 country.
United States1 site
McDaniel Institute of Anti Aging Research
Virginia Beach, Virginia, 23462
About this study
Official title: Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using a 755nm Alexandrite Laser.
- Conditions
- Wrinkles
- Being tested
- 755nm Alexandrite Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
755nm Alexandrite LaserDevice
755nm Alexandrite Laser for the treatment of Wrinkles
| Study group | Role | What they receive |
|---|---|---|
| 755nm Alexandrite Laser | Experimental | 755nm Alexandrite Laser Receives: Device: 755nm Alexandrite Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluation of Wrinkle Severity at Baseline
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Measured: Baseline
Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Measured: 1 Month Follow Up Post Last Treatment
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Measured: 3 Month Follow Up Post Last Treatment
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Measured: 4 Month Follow Up Post Last Treatment
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Measured: 6 Month Follow Up 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 posted19 Mar 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
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.
- Other trials for 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091102
- Sponsor's protocol ID
- CYN13-PICO-LENS-DM
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2014
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
- ClinicalTrials.gov ID
- NCT02091102
- Acronym / sponsor ID
- CYN13-PICO-LENS-DM
- Conditions
- Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Posted 25 Nov 2020
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 evaluate the efficacy and safety of the treatment of wrinkles using a 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 | Experimental | Device: 755nm Alexandrite Laser755nm Alexandrite Laser |
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 non-smoking (must have quit 6 months prior) 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 Alexandrite Laser755nm Alexandrite Laser for the treatment of Wrinkles | Device | 755nm Alexandrite Laser |
Primary outcome
Photographic Evaluation of Wrinkle Severity at Baseline
Time frame: Baseline
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment
Time frame: 1 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment
Time frame: 3 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment
Time frame: 4 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment
Time frame: 6 Month Follow Up Post Last Treatment
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 testing 755nm Alexandrite Laser in people with 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 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 25 Nov 2020. 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 25 Nov 2020). 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?
Photographic Evaluation of Wrinkle Severity at Baseline (time frame: Baseline). The study lists 5 primary outcomes in all. 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 25 Nov 2020.