Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00766376
Other study ID # ERf-02
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 30, 2008
Last updated January 6, 2010
Start date July 2007
Est. completion date July 2009

Study information

Verified date January 2010
Source Palomar Medical Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 151
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Erbium laser
Erbium laser treatment. Each subject will undergo up to 6 treatment sessions

Locations

Country Name City State
United States Palomar Medical Technologies, Inc. Burlington Massachusetts
United States Brooke Seckel, MD Concord Massachusetts
United States The University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Skin & Laser Surgery Center Nashua New Hampshire
United States Scripps Clinic Laser & Cosmetic Dermatology San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Palomar Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. participants at three months No
Secondary Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia. participants at three months No
See also
  Status Clinical Trial Phase
Completed NCT04276753 - A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing and Skin Brightening Benefit of the Test Product in Healthy Female Subjects N/A
Completed NCT06125912 - A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging N/A
Completed NCT02580370 - Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines Phase 3
Recruiting NCT01583478 - Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids Phase 4
Completed NCT02003833 - Poly-L-lactic Acid for Skin Quality Phase 4
Completed NCT01447342 - A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines Phase 2/Phase 3
Completed NCT00974480 - Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging N/A
Completed NCT00986570 - Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face Phase 3
Completed NCT00272610 - Topical Vitamin A Versus Vehicle Cream in the Treatment of Aged Skin Phase 2
Recruiting NCT03730649 - Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure Early Phase 1
Completed NCT03312543 - Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles N/A
Active, not recruiting NCT05349799 - TEOSYAL RHA® 1 for Neck Lines, Perioral Lines and Smiling Lines N/A
Completed NCT03677258 - Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy N/A
Withdrawn NCT05854628 - The Role of Red Flavonoid in Photoaging N/A
Completed NCT01981980 - Comparison of the Effects of Carboxytherapy and Radiofrequency on Skin Rejuvenation N/A
Not yet recruiting NCT00767156 - Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging N/A
Recruiting NCT05813054 - Clinical Study to Evaluate the Anti-aging Efficacy of Dermial® N/A
Completed NCT05457491 - Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE) Phase 1
Not yet recruiting NCT04485091 - TCA Peel and Photobiomodulation for Hand Rejuvenation Phase 2
Completed NCT01237977 - Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines Phase 3