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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103127
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : December 19, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

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

Condition or disease Intervention/treatment Phase
Acne Scars Device: 755nm Alexandrite laser with lens array Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
Study Start Date : July 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: 755nm Alexandrite laser with lens array Device: 755nm Alexandrite laser with lens array



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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:

  1. Is a healthy male or female between 18 and 65 years old
  2. Has unwanted acne scars, excluding ice pick scars (Deep atrophic scars that resemble poked holes), and wishes to undergo laser treatments.
  3. Is willing to consent to participate in the study.
  4. 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:

  1. 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.
  2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
  3. The subject has active or localized systemic infections.
  4. 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}).
  5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  6. 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.
  7. The subject has used Accutane within 6 months prior to enrollment.
  8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
  9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
  10. The subject has a history of keloids.
  11. The subject has evidence of compromised wound healing.
  12. The subject has a history of squamous cell carcinoma or melanoma.
  13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  14. The subject has an allergy to lidocaine and epinephrine.

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): NCT02103127


Locations
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United States, California
Laser & Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Patricia Krantz Cynosure, Inc.
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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT02103127    
Other Study ID Numbers: CYN13-PCAP-AS-SK02
First Posted: April 3, 2014    Key Record Dates
Results First Posted: December 19, 2020
Last Update Posted: January 15, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases