Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment

Completed · Not applicable

Conditions studied: Scarring, Acne

In brief

The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.

Key facts

Study ID

NCT03430921

Run by

Cutera Inc.

People needed

4

Starts

2017-08-15

Expected to finish

2018-05-30

Last updated by the study team

2023-09-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• Subject desires treatment for acne scars and wishes to undergo laser treatments for improvement.
• Subject has bilateral moderate to severe signs of facial acne scarring.
• Must be willing to have Cutera enlighten laser with the Micro-Lens Array handpiece attachment 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 procedure(s) or treatment(s) for acne scars 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 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 procedures, facial fillers, i.e. (Bellafill) and those used for general aesthetic correction, facial peel, lightening creams, or facial surgery.
• 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.
• Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 10,000 units per day) within 12 months of initial treatment or plans on using during the course of the study (note: skin must regain its normal degree of moisture prior to treatment, e.g. lack of noticeable skin flaking and peeling).
• Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
• Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.

Where it is running

• Cutera Research Center — Brisbane, California, United States

Full record on ClinicalTrials.gov

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