Back to resultsThe Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
Primary Purpose
Acne Scars
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SmartLipo Triplex laser system along with the SideLaze800 hand piece
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars
Eligibility Criteria
Inclusion Criteria:
- A healthy male or female between 18 and 65 years old
- Has unwanted facial acne scars and wishes to undergo laser treatments.
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending 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 the heavy use of aspirin) {greater than 81 mg per day}).
- 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 the planned treatment area 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.
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Sites / Locations
- New Jersey Plastic Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SmartLipo Triplex laser system along with the SideLaze800 hand
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs.
Secondary Outcome Measures
Investigator Satisfaction Questionnaire
The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
Subject Satisfaction Questionnaire
The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02103816
Brief Title
The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
Official Title
The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study to evaluate the SmartLipo Triplex laser system along with the SideLaze800 hand piece in the treatment of Acne Scars.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SmartLipo Triplex laser system along with the SideLaze800 hand
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SmartLipo Triplex laser system along with the SideLaze800 hand piece
Primary Outcome Measure Information:
Title
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
Description
This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs.
Time Frame
3 months post treatment
Secondary Outcome Measure Information:
Title
Investigator Satisfaction Questionnaire
Description
The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
Time Frame
3 months post treatment
Title
Subject Satisfaction Questionnaire
Description
The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
Time Frame
3 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A healthy male or female between 18 and 65 years old
Has unwanted facial acne scars and wishes to undergo laser treatments.
Is willing to consent to participate in the study.
Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending 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 the heavy use of aspirin) {greater than 81 mg per day}).
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 the planned treatment area 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.
The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Krantz
Organizational Affiliation
Cynosure, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
New Jersey Plastic Surgery
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
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