Study of a Novel Laser for Skin Rejuvenation

NCT02910492 | Completed Results

• 1 other identifier: C-16-EN12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Rejuvenation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Investigational Enlighten Device

EXPERIMENTAL

Laser treatment for facial skin rejuvenation with the experimental enLighten Laser

Device: enLighten Laser

Interventions

enLighten Laser DEVICE

Dual-pulse duration laser for the treatment of skin rejuvenation

Investigational Enlighten Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (2)

Cutera Research Clinic

Brisbane, California, 94005, United States

Location

Connecticut Skin Institute

Stamford, Connecticut, 06905, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Study Officials

• Stephen Ronan, MD

  Cutera Research Center

  PRINCIPAL INVESTIGATOR

• Omar Ibrahimi, MD

  Connecticut Skin Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 15, 2023
• Results First Posted: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)