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755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01745627
First received: December 6, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars


Condition Intervention
Benign Pigmented and Vascular Lesions and Scars
 Device: 755nm Alex laser

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • Evaluate aesthetic improvement based on photographic scale [ Time Frame: 1 and 3 months post last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histology based on tissue biopsy [ Time Frame: 3 months post last treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser Treatment Device: 755nm Alex laser

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female subjects between 18 and 85 years of age.
  2. Subjects with Fitzpatrick skin types I to VI.
  3. Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
  4. Subject who are willing to consent to participate in the study.

4.2 Exclusion Criteria

  1. Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
  2. Hypersensitive to light exposure.
  3. Active localized or systemic infections.
  4. Taking medication for which sunlight is a contraindication.
  5. History of squamous cell carcinoma or melanoma.
  6. History of keloid scarring.
  7. Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
  8. Prior treatment with laser or other devices in treatment area within 3 months
  9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  10. Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.

  11. Subjects that the physician determines ineligible based on standard of care treatment.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745627

Locations
United States, New York
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
Cynosure, Inc.
Investigators
Study Director: Patricia Krantz Cynosure, Inc.
  More Information

No publications provided

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01745627     History of Changes
Other Study ID Numbers: CYN11-PICO_RG2_PL
Study First Received: December 6, 2012
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013