Study of a Novel Laser for Skin Rejuvenation

A Single-Center, Open-Label Exploratory Study of a Novel Laser for Skin Rejuvenation

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

Study Overview

• Status: Completed
• Conditions: Rejuvenation
• Intervention / Treatment: Device: enLighten Laser

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 laser treatments, and will be followed at 12 weeks post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Hammond, MD; Phone Number: 1-415-657-5538; Email: mhammond@cutera.com
• Study Contact Backup: Name: Ginger Pocock; Phone Number: 1-415-657-5702; Email: gpocock@cutera.com

Study Locations

• United States
  • California
    • Brisbane, California, United States, 94005
      • Cutera Research Clinic
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Connecticut Skin Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female or Male, 18 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Enlighten Device; Laser treatment for facial skin rejuvenation with the experimental enLighten Laser	Device: enLighten Laser; Dual-pulse duration laser for the treatment of skin rejuvenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement).	Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant Clearing 3=Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing	12 weeks post-final treatment, an average of 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of improvement as assessed by the Investigator (Physician's Global Assessment of Improvement).	Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement).	12 weeks post-final treatment
Subject Satisfaction as assessed by Subject Satisfaction Assessment Scale	Subject satisfaction levels at 12 weeks post-final treatment as assessed by Subject Satisfaction Assessment Scale.	12 weeks post-final treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Stephen Ronan, MD, Cutera Research Center; Principal Investigator: Omar Ibrahimi, MD, Connecticut Skin Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimated): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-16-EN12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO