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

COMPLETEDNA

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

NCT03424148•Cutera Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This is an open-label, prospective, study in approximately 60 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of rhytides, lentigines, pigmentation, erythema, telangiectasia, pore size and skin texture. Subjects may undergo a 2mm punch biopsy a treatment area up to 72 hours post treatment and at a designated follow-up period per Investigator discretion. Subjects will receive laser treatments. Subjects will return to the site after final study treatment for two follow-up visits: 6 and 12 weeks.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject must be able to read, understand and sign the Informed Consent Form.
•2. Female or Male, 18 to 65 years of age (inclusive).
•3. Fitzpatrick Skin Type I - VI.
•4. 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.
•5. 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.
•6. 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.
•7. 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.
•8. 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.,

Exclusion Criteria

•1. 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.
•2. 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.
•3. 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.
•4. 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).
•5. Pregnant and/or breastfeeding, or planning to become pregnant.
•6. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
•7. Hypersensitivity to light exposure.
•8. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
•9. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
•10. Has a history of squamous cell carcinoma or melanoma in the treatment area.
+9 more criteria

Locations (2)

Cutera Research Center

Brisbane, California, United States

Center for Dermatology and Laser Surgery

Sacramento, California, United States

Key Dates

Start Date

February 20, 2018

Primary Completion Date

November 27, 2018

Completion Date

November 27, 2018

Last Updated

September 14, 2023

Enrollment

ACTUAL participants

Conditions

ScarringSkin Aging

Interventions

Excel V™ Laser & Micro-Lens Array Attach

DEVICE

Losartan for Corneal Fibrosis

NCT07449000

Corneal Scarring Fibrosis

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RECRUITINGNA

Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure

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Scarring

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RECRUITINGPHASE3

Novel Strategies for Reducing Burn Scar Itch

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Burn Scar

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Losartan for Corneal Fibrosis

Aesthetic Outcome of Intra-dermal Versus Transcutaneous Purse-string Closure

Novel Strategies for Reducing Burn Scar Itch

Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp

Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns

MENA Consensus on Poly-L-Lactic Acid (PLLA) Biostimulator Use in Aesthetic Dermatology