enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars

NCT03284333 | Completed Results FDA Device

• 1 other identifier: C-17-ML02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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 Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne scars.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (1)

• Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.

  visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)

  12 weeks post-final treatment

Study Arms (1)

other

EXPERIMENTAL

no arm

Device: other

Interventions

other DEVICE

no arm

other

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 (Appendix 6).
• 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. 6. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
• \. Hypersensitivity to light exposure. 8. 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. 11. 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (2)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Sadick Dermatology/Sadick Research Center

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-357-5518

Study Officials

• Stephen Ronan, M.D.

  Cutera Research Center

  PRINCIPAL INVESTIGATOR

• Neil Sadick, M.D.

  Sadick Dermatology/Sadick 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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 15, 2017
• Study Start: July 27, 2017
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)