A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation

NCT03421691 | Completed Results FDA Device

• 1 other identifier: C-16-EV10
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel V Laser Genesis procedure utilizing the 1064nm laser for skin rejuvenation.

Conditions

Skin Pigment; Photoaging

Outcome Measures

Primary Outcomes (1)

• Degree of Improvement Rating at 12 Weeks Post-final Treatment

  The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes * 4=Very Significant Improvement * 3=Significant Improvement * 2=Moderate Improvement * 1=Mild Improvement 0=No Change(

  12 weeks post-final treatment

Study Arms (1)

Excel V laser

OTHER

excel V Laser Genesis procedure utilizing 1064 nm laser

Device: excel V Laser

Interventions

excel V Laser DEVICE

excel V Laser Genesis procedure utilizing 1064 nm laser

Excel V laser

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female or Male, 35 to 55 years of age (inclusive).
• Fitzpatrick Skin Type I - IV.
• Desires non-invasive and non-ablative treatment of skin-aging or photo-rejuvenation of the skin.
• Have signs of moderate skin aging, including presence of mild to moderate rhytides around eyes and upper lip, multiple lentigines, diffuse erythema or telangiectasia, and a score between 4 and 7 (inclusive) on the Fitzpatrick Wrinkle Classification Scale.
• 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 30 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) for skin rejuvenation during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment.
• Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler during 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 or to father a child for the duration of the study.

You may not qualify if:

• Participation in a clinical trial of another device or drug 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 to the face of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation, as applicable.
• Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
• Use of topical medications on the face, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration \> 8%, within 1 month of 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 medication which might make study participation unsafe according to Investigator's discretion.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Skin Laser and Surgery Specialists of NY and NJ

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 5, 2018
• Study Start: March 15, 2016
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: September 6, 2023
• Results First Posted: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)