Safety and Efficacy Evaluation of Erbium Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Palomar Medical Technologies, Inc..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Palomar Medical Technologies, Inc.
Information provided by:
Palomar Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00766376
First received: September 30, 2008
Last updated: January 6, 2010
Last verified: January 2010
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Purpose
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
| Condition | Intervention |
|---|---|
|
Skin Aging |
Device: Erbium laser |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy Evaluation of Fractional Erbium Treatment |
Resource links provided by NLM:
Further study details as provided by Palomar Medical Technologies, Inc.:
Primary Outcome Measures:
- Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. [ Time Frame: participants at three months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. [ Time Frame: participants at three months ] [ Designated as safety issue: No ]
| Enrollment: | 151 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: Erbium laser
Erbium laser treatment. Each subject will undergo up to 6 treatment sessions
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 follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766376
Locations
| United States, California | |
| Scripps Clinic Laser & Cosmetic Dermatology | |
| San Diego, California, United States, 92130 | |
| United States, Massachusetts | |
| Palomar Medical Technologies, Inc. | |
| Burlington, Massachusetts, United States, 01803 | |
| Brooke Seckel, MD | |
| Concord, Massachusetts, United States, 01742 | |
| United States, New Hampshire | |
| Skin & Laser Surgery Center | |
| Nashua, New Hampshire, United States, 03060 | |
| United States, Texas | |
| The University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
Sponsors and Collaborators
Palomar Medical Technologies, Inc.
More Information
No publications provided
| Responsible Party: | Medical Director, Palomar Medical Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT00766376 History of Changes |
| Other Study ID Numbers: | ERf-02 |
| Study First Received: | September 30, 2008 |
| Results First Received: | January 6, 2010 |
| Last Updated: | January 6, 2010 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 16, 2013