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

NCT02103816 | Completed Results

• 1 other identifier: CYN13-PRECIS-ACNE-BD
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale

  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 Outcomes (2)

• Investigator Satisfaction Questionnaire

  3 months post treatment

• Subject Satisfaction Questionnaire

  3 months post treatment

Study Arms (1)

SmartLipo Triplex laser system along with the SideLaze800 hand

EXPERIMENTAL

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

Interventions

SmartLipo Triplex laser system along with the SideLaze800 hand piece DEVICE

SmartLipo Triplex laser system along with the SideLaze800 hand

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Results Point of Contact

• Title: Jamie Trimper
• Organization: Cynosure

jamie.trimper@cynosure.com

800-886-2966

Study Officials

• Patricia Krantz

  Cynosure, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-12

Locations

US (1)