COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01745627
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : February 10, 2014
Information provided by (Responsible Party):
Cynosure, Inc.

Brief Summary:
Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars

Condition or disease Intervention/treatment Phase
Benign Pigmented and Vascular Lesions and Scars Device: 755nm Alex laser Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Laser Treatment Device: 755nm Alex laser

Primary Outcome Measures :
  1. Evaluate aesthetic improvement based on photographic scale [ Time Frame: 1 and 3 months post last treatment ]

Secondary Outcome Measures :
  1. Histology based on tissue biopsy [ Time Frame: 3 months post last treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy male or female subjects between 18 and 85 years of age.
  2. Subjects with Fitzpatrick skin types I to VI.
  3. Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
  4. Subject who are willing to consent to participate in the study.

4.2 Exclusion Criteria

  1. Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
  2. Hypersensitive to light exposure.
  3. Active localized or systemic infections.
  4. Taking medication for which sunlight is a contraindication.
  5. History of squamous cell carcinoma or melanoma.
  6. History of keloid scarring.
  7. Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
  8. Prior treatment with laser or other devices in treatment area within 3 months
  9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  10. Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
  11. Subjects that the physician determines ineligible based on standard of care treatment.



Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01745627

Layout table for location information
United States, New York
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
Cynosure, Inc.
Layout table for investigator information
Study Director: Patricia Krantz Cynosure, Inc.
Layout table for additonal information
Responsible Party: Cynosure, Inc. Identifier: NCT01745627    
Other Study ID Numbers: CYN11-PICO_RG2_PL
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014