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

Exclusion Criteria

• •1\. 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.
• •2\. 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.
• •3\. 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.
• •4\. 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).
• •5\. 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.
• •7\. Hypersensitivity to light exposure. 8. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
• •9\. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
• •10\. 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.
• •12\. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
• •13\. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• •14\. 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.
• •15\. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator.
• •16\. 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).
• •17\. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
• •19\. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
• •20\. 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.
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