755nm Alex Laser for Treatment of Stretch Marks

Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.

Study Overview

• Status: Completed
• Conditions: Striae
• Intervention / Treatment: Device: 755nm Alexandrite Laser

• Study Type: Interventional
• Enrollment (Actual): 45
• 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 striae and wishes to undergo laser treatments to remove or improve them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 755nm Alexandrite laser with array handpiece; Device: 755nm Alexandrite laser with array handpiece	Device: 755nm Alexandrite Laser; 755nm Alexandrite laser with array handpiece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic Evaluation of Striae Clearance	The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.	Follow Up Between 1 and 3 Months Post Last Treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CYN12-PICO-STRIAE_RG4