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Evaluation of the 755nm Alexandrite Laser for Skin Toning and Epidermal Pigmented Lesions in Asian Skin Types

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: NCT01754246
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : October 27, 2020
Information provided by (Responsible Party):
Cynosure, Inc.

Brief Summary:
The purpose of this study is to assess treatment for facial skin toning and removal of epidermal pigmented lesions for Asian patients using the 755nm Alexandrite laser

Condition or disease Intervention/treatment Phase
Epidermal Pigmented Lesions Skin Toning Device: 755nm Alexandrite Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are put into two groups (Pigmented Lesions/Skin Toning) to test prototype design and operating specifications. It is not a full clinical trial.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Alexandrite Laser for Skin Toning
755 nm Alexandrite Laser for Skin Toning
Device: 755nm Alexandrite Laser
755nm Alexandrite laser for treatment of epidermal pigmented lesions and skin toning in Asian skin types

Experimental: Alexandrite Laser for Pigmented Lesions
755nm Alexandrite Laser for Epidermal Pigmented Lesions
Device: 755nm Alexandrite Laser
755nm Alexandrite laser for treatment of epidermal pigmented lesions and skin toning in Asian skin types

Primary Outcome Measures :
  1. Photographic Evaluation [ Time Frame: up to 4 months post last treatment ]
    2D Photography to assess progress pre and post 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.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Is a healthy male or female between 18 and 85 years old
  2. Has unwanted facial epidermal pigmented lesions or desires facial skin toning 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 being photographed, following post treatment care and attending all treatment and follow up visits.
  5. Has Fitzpatrick skin types III 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 or hypertrophic scarring.
  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. Allergic to topical lidocaine or topical steroids

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): NCT01754246

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United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Cynosure, Inc.
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Study Director: Patricia Krantz Cynosure, Inc.
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Responsible Party: Cynosure, Inc. Identifier: NCT01754246    
Other Study ID Numbers: CYN12-PICO-PLASIAN
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020