The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars

Cynosure

Status: Completed

Conditions: Acne Scars

Treatments: Device: SmartLipo Triplex laser system along with the SideLaze800 hand piece

Study type: Interventional

Funder types: Industry

Identifiers

NCT02103816

CYN13-PRECIS-ACNE-BD

Details and patient eligibility

About

The purpose of this study to evaluate the SmartLipo Triplex laser system along with the SideLaze800 hand piece in the treatment of Acne Scars.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

SmartLipo Triplex laser system along with the SideLaze800 hand

Experimental group

Treatment:

Device: SmartLipo Triplex laser system along with the SideLaze800 hand piece