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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.

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date October 26, 2020
Study Start Date  ICMJE December 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Photographic Evaluation [ Time Frame: up to 4 months post last treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Reporting of Adverse Events [ Time Frame: up to 4 months post last treatment ]
  • Satisfaction Questionnaire [ Time Frame: up to 4 months post treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Dermal and Epidermal Pigmented Lesions
Intervention  ICMJE Device: 755nm Alexandrite Laser
755nm Alexandrite Laser for epidermal and dermal pigmented lesions
Study Arms  ICMJE Experimental: 755nm Alexandrite Laser
755nm Alexandrite Laser
Intervention: Device: 755nm Alexandrite Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2015)
6
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
20
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754233
Other Study ID Numbers  ICMJE CYN12-PICO-PL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynosure, Inc.
Study Sponsor  ICMJE Cynosure, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patricia Krantz Cynosure, Inc.
PRS Account Cynosure, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP