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

NCT02103127 | Completed Results

• 1 other identifier: CYN13-PCAP-AS-SK02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Investigator Satisfaction Questionnaire

  3 months post treatment

• Subject Satisfaction Questionnaire

  3 months post treatment

Study Arms (1)

755nm Alexandrite laser with lens array

EXPERIMENTAL

Device: 755nm Alexandrite laser with lens array

Interventions

755nm Alexandrite laser with lens array DEVICE

755nm Alexandrite laser with lens array

Eligibility Criteria

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

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

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: March 31, 2014
• First Posted: April 3, 2014
• Study Start: July 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 15, 2021
• Results First Posted: December 19, 2020

Record last verified: 2020-12

Locations

US (1)