- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091102
Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
November 3, 2020 updated by: Cynosure, Inc.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Virginia Beach, Virginia, United States, 23462
- McDaniel Institute of Anti Aging Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 755nm Alexandrite Laser
|
755nm Alexandrite Laser for the treatment of Wrinkles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
1 Month Follow Up Post Last Treatment
|
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.
|
3 Month Follow Up Post Last Treatment
|
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.
|
4 Month Follow Up Post Last Treatment
|
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.
|
6 Month Follow Up Post Last Treatment
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Satisfaction Questionnaire
Time Frame: up to 6 months post last treatment
|
up to 6 months post last treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
March 17, 2014
First Submitted That Met QC Criteria
March 17, 2014
First Posted (Estimate)
March 19, 2014
Study Record Updates
Last Update Posted (Actual)
November 25, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- CYN13-PICO-LENS-DM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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