- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02103816
The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
December 16, 2020 updated by: Cynosure, Inc.
The purpose of this study to evaluate the SmartLipo Triplex laser system along with the SideLaze800 hand piece in the treatment of Acne Scars.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
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
-
-
New Jersey
-
Montclair, New Jersey, United States, 07042
- New Jersey Plastic 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:
- 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.
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: SmartLipo Triplex laser system along with the SideLaze800 hand
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
Time Frame: 3 months post treatment
|
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.
|
3 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigator Satisfaction Questionnaire
Time Frame: 3 months post treatment
|
The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
|
3 months post treatment
|
Subject Satisfaction Questionnaire
Time Frame: 3 months post treatment
|
The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
|
3 months post 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
October 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
April 1, 2014
First Submitted That Met QC Criteria
April 1, 2014
First Posted (Estimate)
April 4, 2014
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYN13-PRECIS-ACNE-BD
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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