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

NCT03430921 | Completed Results FDA Device

• 1 other identifier: C-17-ML03
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Scarring; Acne

Outcome Measures

Primary Outcomes (1)

• Acne Scarring Improvement

  An improvement in Acne Scarring of at least one point on the Acne Scar Assessment Scale (ASAS):(1=clear scarring, 2=Very Mild scarring, 3=Mild scarring, 4=Moderate scarring or 5=Severe scarring) at the 12 weeks post final treatment

  Baseline, and at 12 weeks post final treatment (up to 30 weeks)

Study Arms (1)

Enlighten™ Laser and a MLA Attachment

OTHER

Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment

Device: Enlighten™ Laser and a MLA Attachment

Interventions

Enlighten™ Laser and a MLA Attachment DEVICE

Subjects will receive treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment.

Enlighten™ Laser and a MLA 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.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Cutera Research Center

Brisbane, California, 94005, United States

Location

MeSH Terms

Conditions

Cicatrix; Acne Vulgaris

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Study Officials

• Stephen Ronan, M.D.

  Cutera Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 13, 2018
• Study Start: August 15, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: September 26, 2023
• Results First Posted: September 26, 2023

Record last verified: 2023-09

Locations

US (1)