Back to resultsEvaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
Primary Purpose
Acne Scars
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
755nm Alexandrite laser with lens array
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars
Eligibility Criteria
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.
Sites / Locations
- Laser & Skin Surgery Center of Northern California
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
755nm Alexandrite laser with lens array
Arm Description
Outcomes
Primary Outcome Measures
Severity Change in Acne Scarring
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).
Severity Change in Acne Scarring
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
Investigator Satisfaction Questionnaire
Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Subject Satisfaction Questionnaire
Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02103127
Brief Title
Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
Official Title
Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess treatment of facial acne scars using the 755nm Alexandrite Laser with lens arrays.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
755nm Alexandrite laser with lens array
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
755nm Alexandrite laser with lens array
Primary Outcome Measure Information:
Title
Severity Change in Acne Scarring
Description
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).
Time Frame
Baseline and 1 month post treatment
Title
Severity Change in Acne Scarring
Description
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).
Time Frame
Baseline and 3 months post treatment
Secondary Outcome Measure Information:
Title
Investigator Satisfaction Questionnaire
Description
Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Time Frame
3 months post treatment
Title
Subject Satisfaction Questionnaire
Description
Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Time Frame
3 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Krantz
Organizational Affiliation
Cynosure, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Laser & Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Picosure 755nm Alexandrite Laser With Lens Array for the Treatment of Acne Scars
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