Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars

Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.

Study Overview

• Status: Completed
• Conditions: Scars
• Intervention / Treatment: Device: 755nm Alexandrite Laser with handpiece 2; Device: 755nm Alexandrite Laser with handpiece 3; Device: 755nm Alexandrite Laser with handpiece 1

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old
2. Has unwanted scars not including atrophic scars 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.
5. Has Fitzpatrick skin types I to IV.

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 subjects has an allergy to lidocaine and epinephrine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 755nm Alexandrite Laser with Handpiece 2; Focusing energy on skin	Device: 755nm Alexandrite Laser with handpiece 2; Focusing energy on skin
Experimental: 755nm Alexandrite Laser with handpiece 3; Focusing energy on skin	Device: 755nm Alexandrite Laser with handpiece 3; Focusing energy on skin
Experimental: 755nm Alexandrite laser with handpiece 1; Focusing energy on skin	Device: 755nm Alexandrite Laser with handpiece 1; focusing energy at skin surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Biopsy Sampling	Histological examination of tissue samples will be compared between baseline and 3 months post treatment.	3 months post last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic evaluation as a measure of improvement.	2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement.	up to 3 months post last treatment
Subject Biopsy Sampling	Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment.	2 weeks post treatment
Subject Biopsy Sampling	Histological examination of tissue samples will be compared between baseline and 1 month post treatment.	1 month post treatment

Other Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events as a measure of safety and tolerability	up to 3 months post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CYN12-PICO-CAPHST-07