- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107157
Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation
January 19, 2021 updated by: Cynosure, Inc.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
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
-
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California
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Sacramento, California, United States, 95819
- Dermatology and Laser Surgery
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-
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 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 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.
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 with cap array
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline and 3 months post last treatment
|
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.
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Baseline and 3 months post last treatment
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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.
|
3 months post last treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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
July 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
March 31, 2014
First Submitted That Met QC Criteria
April 4, 2014
First Posted (Estimate)
April 8, 2014
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 19, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYN13-PICO-CAPHST-ET
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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