| Eligibility |
Inclusion Criteria:
1. Subject must be able to read, understand and sign the Informed Consent Form.
2. Female or Male, 18 to 65 years of age (inclusive).
3. Fitzpatrick Skin Type I - VI (Appendix 6).
4. Subject desires treatment for acne scars and wishes to undergo laser treatments for
improvement.
5. Subject has bilateral moderate to severe signs of facial acne scarring.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.,
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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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