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

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.
 
ClinicalTrials.gov Identifier: NCT01754233
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Study Description
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Brief Summary:
The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Study Start Date : December 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: 755nm Alexandrite Laser
755nm Alexandrite Laser
 Device: 755nm Alexandrite Laser
755nm Alexandrite Laser for epidermal and dermal pigmented lesions


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

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

Eligibility Criteria
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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
Criteria

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
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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 ClinicalTrials.gov identifier (NCT number): NCT01754233


Locations
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United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Patricia Krantz Cynosure, Inc.
More Information
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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01754233    
Other Study ID Numbers: CYN12-PICO-PL
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020