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Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions

This study has been completed.
Information provided by (Responsible Party):
Cynosure, Inc. Identifier:
First received: December 18, 2012
Last updated: July 29, 2015
Last verified: July 2015
The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.

Condition Intervention
Dermal and Epidermal Pigmented Lesions Device: 755nm Alexandrite Laser

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Photographic Evaluation [ Time Frame: up to 4 months post last treatment ]

Secondary Outcome Measures:
  • Reporting of Adverse Events [ Time Frame: up to 4 months post last treatment ]
  • Satisfaction Questionnaire [ Time Frame: up to 4 months post treatment ]

Enrollment: 6
Study Start Date: December 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 755nm Alexandrite Laser
755nm Alexandrite Laser
Device: 755nm Alexandrite Laser
755nm Alexandrite Laser for epidermal and dermal pigmented lesions


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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 dermal and/or epidermal pigmented lesions or desires 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 any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  5. 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.
  6. The subject has used Accutane within 6 months prior to enrollment.
  7. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
  8. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
  9. The subjects had prior treatment with laser or other devices in the treatment area within 3 months.
  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. Is allergic to topical lidocaine or topical steroids.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01754233

United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Cynosure, Inc.
Study Director: Patricia Krantz Cynosure, Inc.
  More Information

Responsible Party: Cynosure, Inc. Identifier: NCT01754233     History of Changes
Other Study ID Numbers: CYN12-PICO-PL
Study First Received: December 18, 2012
Last Updated: July 29, 2015 processed this record on September 21, 2017