Clinical trial NCT02103816: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scars
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
timeFrame: 3 months post treatment
Secondary outcomes:
measure: Investigator Satisfaction Questionnaire
timeFrame: 3 months post treatment
measure: Subject Satisfaction Questionnaire
timeFrame: 3 months post treatment
Other outcomes:
Locations:
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References: