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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01754246
First received: December 18, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention
Epidermal Pigmented Lesions
Skin Toning
Device: 755nm Alexandrite Laser

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    2D Photography to assess progress pre and post treatment


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01754246

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

No publications provided

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01754246     History of Changes
Other Study ID Numbers: CYN12-PICO-PLASIAN
Study First Received: December 18, 2012
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 01, 2014