Status:
COMPLETED
Evaluation of the Cutera Enlighten™ Laser With Micro-Lens Array (MLA) Handpiece Attachment
Lead Sponsor:
Cutera Inc.
Conditions:
Scarring
Acne
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 micr...
Detailed Description
This is an open-label, prospective, multicenter, pivotal study in approximately 15 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of moderate to severe acne...
Eligibility Criteria
Inclusion
- 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.,
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03430921
Start Date
August 15 2017
End Date
May 30 2018
Last Update
September 26 2023
Active Locations (1)
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1
Cutera Research Center
Brisbane, California, United States, 94005