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

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ClinicalTrials.gov Identifier: NCT02103816
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

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.

Condition or disease Intervention/treatment Phase
Acne Scars Device: SmartLipo Triplex laser system along with the SideLaze800 hand piece Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Smartlipo Triplex 1440nm Wavelength Laser and the Sidelaze 800 Hand Piece for the Treatment of Facial Acne Scars
Study Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: SmartLipo Triplex laser system along with the SideLaze800 hand Device: SmartLipo Triplex laser system along with the SideLaze800 hand piece



Primary Outcome Measures :
  1. To assess level of improvement using the Global Acne Scarring Scale through photographic evaluation. [ Time Frame: up to 9 months post treatment ]

Secondary Outcome Measures :
  1. Investigator and subject satisfaction questionnaire [ Time Frame: up to 9 months post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103816


Locations
United States, New Jersey
New Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042
Sponsors and Collaborators
Cynosure, Inc.
Investigators
Study Director: Patricia Krantz Cynosure, Inc.

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT02103816     History of Changes
Other Study ID Numbers: CYN13-PRECIS-ACNE-BD
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015