Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment

NCT03424148 | Completed Results FDA Device

• 1 other identifier: C-17-EV11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Open-label, Prospective, Study to Evaluate the Cutera excel V laser at 532 nm in a low fluence, high repetition rate mode and the Micro-Lens Array attachment used with excel V laser at 1064 nm and 532 nm for the improvement of skin quality.

Conditions

Scarring; Skin Aging

Outcome Measures

Primary Outcomes (1)

• Study Effectiveness for Skin Aesthetic Improvement

  Efficacy of treatment(s) with Cutera excel V™ laser and the Micro-Lens Array attachment as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale Higher scores indicate better outcomes (+4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, or 0=No Change) Subjects had one assessment done at either the 6 or 12 week follow up, and GAIS values from the 6 and 12 week follow up visits were summed together to calculate the mean

  6 or 12 weeks after the final treatment

Study Arms (1)

Excel V™ Laser & Micro-Lens Array Attachment

OTHER

Treatment with Excel V™ Laser and a Micro-Lens Array Attachment for skin quality

Device: Excel V™ Laser & Micro-Lens Array Attach

Interventions

Excel V™ Laser & Micro-Lens Array Attach DEVICE

Subjects will receive laser treatments

Excel V™ Laser & Micro-Lens Array Attachment

Eligibility Criteria

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

You may qualify if:

• Subject must be able to read, understand and sign the Informed Consent Form.
• Female or Male, 18 to 65 years of age (inclusive).
• Fitzpatrick Skin Type I - VI.
• Must be willing to have Cutera excel V laser treatments and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.
• Willing to have very limited sun exposure and use sunscreen 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 and/or marketing), publications, and any additional marketing purposes.
• Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the face during the study and has no intention of having such procedures performed during the course of the study.
• For female subjects: not pregnant or lactating and is either post-menopausal, 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.,

You may not qualify if:

• Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 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 procedures, facial fillers, toxins and those used for general aesthetic correction.
• Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
• Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
• Pregnant and/or breastfeeding, or planning to become pregnant.
• Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
• Hypersensitivity to light exposure.
• Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
• History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
• Has a history of squamous cell carcinoma or melanoma in the treatment area.
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
• A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• 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, or any that are considered not acceptable by the study investigator.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (2)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Margout 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 24, 2018
• First Posted: February 6, 2018
• Study Start: February 20, 2018
• Primary Completion: November 27, 2018
• Study Completion: November 27, 2018
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-08

Locations

US (2)