Study of a Novel Microlens Array Device for Skin Rejuvenation

NCT02888626 | Completed Results FDA Device

• 1 other identifier: C-16-ML01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser treatments and will be followed at 12 weeks post-final treatment.

Conditions

Wrinkles; Scars

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment of Improvement

  Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator. Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement 1= Moderate Improvement 0= Mild or No Improvement

  12 weeks post final treatment

Study Arms (1)

Treatment with Microlens Array

EXPERIMENTAL

Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser

Device: Microlens Array

Interventions

Microlens Array DEVICE

Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser

Treatment with Microlens Array

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 of fine rhytides, pigmentation, erythema or telangiectasia.
• 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, within 6 months prior to enrollment or 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, scars, 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.
• Suffering from coagulation disorders or taking prescription anticoagulation medications.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• 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 (1)

Cutera Research Center

Brisbane, California, 94005, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Study Officials

• Stephen Ronan, MD

  P.I.

  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: August 23, 2016
• First Posted: September 5, 2016
• Study Start: August 1, 2016
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: August 15, 2023
• Results First Posted: August 15, 2023

Record last verified: 2023-07

Locations

US (1)