Study of a Novel Laser for Skin Rejuvenation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02910492|
Recruitment Status : Unknown
Verified September 2016 by Cutera Inc..
Recruitment status was: Recruiting
First Posted : September 22, 2016
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rejuvenation||Device: enLighten Laser||Not Applicable|
A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.
Subjects will receive up to 7 laser treatments, spaced 1 to 8 weeks apart, and will be followed at 2 weeks (±1 week) post-first treatment and 12 weeks (±2 weeks) post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up. At the Investigator's discretion, optional follow-up visits may also be conducted at 6 weeks post-final treatment (±2 weeks).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center, Open-Label Exploratory Study of a Novel Laser for Skin Rejuvenation|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Investigational Enlighten Device
Laser treatment for facial skin rejuvenation with the experimental enLighten Laser
Device: enLighten Laser
Nd:YAG dual-pulse duration laser for the treatment of skin rejuvenation
- Adverse Device Effects at 2 weeks post-first treatment. [ Time Frame: 2 weeks post-first treatment ]Incidence and severity of adverse device effects at 2 weeks post-first treatment.
- Degree of improvement as assessed by the Investigator (Physician's Global Assessment of Improvement). [ Time Frame: 12 weeks post-final treatment ]Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement).
- Subject Satisfaction as assessed by Subject Satisfaction Assessment Scale [ Time Frame: 12 weeks post-final treatment ]Subject satisfaction levels at 12 weeks post-final treatment as assessed by Subject Satisfaction Assessment Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910492
|Contact: Matthew Hammond, MDemail@example.com|
|Contact: Ginger Pocockfirstname.lastname@example.org|
|United States, California|
|Cutera Research Clinic||Recruiting|
|Brisbane, California, United States, 94005|
|Contact: Mischell San Juan 415-657-5544 email@example.com|
|United States, Connecticut|
|Connecticut Skin Institute||Recruiting|
|Stamford, Connecticut, United States, 06905|
|Contact: John Liongson 203-428-4440 firstname.lastname@example.org|
|Principal Investigator: Omar Ibrahimi|
|Principal Investigator:||Stephen Ronan, MD||Cutera Research Center|
|Principal Investigator:||Omar Ibrahimi, MD||Connecticut Skin Institute|