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Completed

NCT Number: NCT02103127

Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars

The purpose of this study is to assess treatment of facial acne scars using the 755nm Alexandrite Laser with lens arrays.

Completed

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is a healthy male or female between 18 and 65 years old
  • Has unwanted acne scars, excluding ice pick scars (Deep atrophic scars that resemble poked holes), 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 biopsies, being photographed, following post treatment care and attending all treatment and 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 heavy aspirin therapy {greater than 81 mg per day}).
  • The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  • 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 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.

Treatment and study plan

755nm Alexandrite laser with lens array

Device

Primary outcomes

  1. Severity Change in Acne Scarring

    Time frame: Baseline and 1 month post treatment

    The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).

  2. Severity Change in Acne Scarring

    Time frame: Baseline and 3 months post treatment

    The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).

Secondary outcomes

  1. Investigator Satisfaction Questionnaire

    Time frame: 3 months post treatment

    Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.

  2. Subject Satisfaction Questionnaire

    Time frame: 3 months post treatment

    Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2014
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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