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Study of a Novel Laser for Skin Rejuvenation

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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
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
Single-center study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.

Condition or disease Intervention/treatment Phase
Rejuvenation Device: enLighten Laser Not Applicable

Detailed Description:

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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female or Male, 20 to 75 years of age (inclusive).
  • Fitzpatrick Skin Type I - VI.
  • Desires photo-rejuvenation of the skin or improvement in the appearance of acne scarring.
  • Subject has visible signs of acne scarring or moderate sun-damaged and/or aging skin in the treatment area with visible areas acne lesions and scars, fine rhytides, lentigines or pigmentation, diffused redness erythema and skin texture
  • Subject must be able to read, understand and sign the Informed Consent Form.
  • Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  • Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
  • Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
  • Agree to not undergo any other procedure(s), including injectable agents, for skin rejuvenation during the study and has no intention of having such procedures performed during the course of the study.
  • Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.

Exclusion Criteria:

  • Participation in a clinical trial of another drug, or device administered to the target area, during the study.
  • Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
  • Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation.
  • History of malignant tumors in the target area.
  • Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
  • Pregnant and/or breastfeeding.
  • Having an infection, dermatitis or a rash in the treatment area.
  • Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
  • History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  • History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications per investigator's discretion.
  • History of vitiligo, eczema, or psoriasis.
  • History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  • History of seizure disorders due to light.
  • Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
  • History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
  • History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
  • Systemic use of retinoid, such as isotretinoin, as applicable, within 6 months of study participation.
  • Topical use of retinoid, such as isotretinoin, as applicable, on the treatment area within 1 month of participation.
  • Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • Current smoker or history of smoking within 6 months of study participation. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Information from the National Library of Medicine

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


Contacts
Contact: Matthew Hammond, MD 1-415-657-5538 mhammond@cutera.com
Contact: Ginger Pocock 1-415-657-5702 gpocock@cutera.com

Locations
United States, California
Cutera Research Clinic Recruiting
Brisbane, California, United States, 94005
Contact: Mischell San Juan    415-657-5544    msanjuan@cutera.com   
United States, Connecticut
Connecticut Skin Institute Recruiting
Stamford, Connecticut, United States, 06905
Contact: John Liongson    203-428-4440    admin@ctskindoc.com   
Principal Investigator: Omar Ibrahimi         
Sponsors and Collaborators
Cutera Inc.
Investigators
Principal Investigator: Stephen Ronan, MD Cutera Research Center
Principal Investigator: Omar Ibrahimi, MD Connecticut Skin Institute

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT02910492     History of Changes
Other Study ID Numbers: C-16-EN12
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No