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

Acne Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103127
• Other study ID #: CYN13-PCAP-AS-SK02
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 2015

Study information

• Verified date: December 2020
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Scars
• Acne Vulgaris
• Cicatrix

Intervention

Device:
• 755nm Alexandrite laser with lens array

Locations

Country	Name	City	State
United States	Laser & Skin Surgery Center of Northern California	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 1 month post treatment
Primary	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).	Baseline and 3 months post treatment
Secondary	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.	3 months post treatment
Secondary	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.	3 months post treatment