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N/A N=4 Treatment

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

Scarring · Acne

Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Acne Scarring Improvement — 4; 4 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Enlighten™ Laser and a MLA Attachment (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Cutera Inc.
Primary completion
May 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Acne Scarring Improvement
4; 4

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 micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03430921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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