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Status:

UNKNOWN

Safety and Efficacy Evaluation of Erbium Treatment

Lead Sponsor:

Palomar Medical Technologies, Inc.

Conditions:

Skin Aging

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.

Detailed Description

The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures. Each subject will undergo up to 6 treatment sessions, with scheduled time-points for foll...

Eligibility Criteria

Inclusion

  • Healthy male and female Adults (18 years or older).
  • Subjects who can read, understand, and sign the Informed Consent Form.
  • Subjects willing and able to comply with all study requirements.

Exclusion

  • Subjects with active localized or systemic infections.
  • Immunocompromised subjects.
  • Subjects with coagulation disorder.
  • History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
  • Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
  • In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
  • Use of Accutane® within the past 6 months.
  • Subjects with a history of radiation therapy to the treatment area.
  • Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
  • Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.

Key Trial Info

Start Date :

July 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2009

Estimated Enrollment :

151 Patients enrolled

Trial Details

Trial ID

NCT00766376

Start Date

July 1 2007

End Date

July 1 2009

Last Update

January 29 2010

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Scripps Clinic Laser & Cosmetic Dermatology

San Diego, California, United States, 92130

2

Palomar Medical Technologies, Inc.

Burlington, Massachusetts, United States, 01803

3

Brooke Seckel, MD

Concord, Massachusetts, United States, 01742

4

Skin & Laser Surgery Center

Nashua, New Hampshire, United States, 03060