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N/A N=21 Treatment

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

Acne Scars

Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale — 28.6; 57.1; 14.3 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SmartLipo Triplex laser system along with the SideLaze800 hand piece (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Cynosure, Inc.
Primary completion
Feb 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
28.6; 57.1; 14.3
SECONDARY
Investigator Satisfaction Questionnaire
6; 5; 3
SECONDARY
Subject Satisfaction Questionnaire
6; 6; 2; 1

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02103816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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