| Eligibility |
Inclusion Criteria:
1. Healthy male, female, and non-binary adults between 18 and 75 years of age
2. Fitzpatrick Skin Phototype V and VI
3. Individuals deemed by the Investigator to have clinically significant
hyperpigmentation on their face and desire treatment and correction of this condition
4. Individuals willing to withhold aesthetic therapies (excluding those explicitly
prescribed by the Investigator as pre-treatment) for the duration of the study
5. Women of childbearing potential who agree to take a urine pregnancy test at the
Screening visit or when deemed by Investigator. Women of childbearing potential must
have a negative urine pregnancy test and must not be lactating at Screening. Women
must be willing and able to use an acceptable method of birth control (see below)
during the study. Women will not be considered of childbearing potential if one or
more of the following is documented:
- Postmenopausal for 12 months prior to initiation of the study
- Without a uterus +/- both ovaries prior to initiation of the study
- Bilateral tubal ligation 6 months prior to initiation of the study
6. Individuals of childbearing potential who use an acceptable method of contraception
for the duration of the study. Acceptable modes of birth control include the
following:
- Established use of hormonal contraception (oral, injectable, implanted, patch or
vaginal ring)
- Barrier methods with spermicide: condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- Intrauterine device (IUD) or intrauterine system (IUS)
- Surgical sterilization (e.g., vasectomy confirmed to be effective by sperm count
check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
- Abstinence from heterosexual intercourse, when this is in line with the preferred
and usual lifestyle of the subject. Periodic abstinence (e.g., calendar,
ovulation, symptothermal, post-ovulation methods) and withdrawal methods are not
acceptable forms of contraception.
7. Individuals who can read, speak, write, and understand English and who are willing to
provide written informed consent.
8. Individuals willing to sign a photography release.
9. Individuals willing and able to cooperate with all study requirements for the duration
of the study, including prescribed pre- and post-procedure topical regimens
Exclusion Criteria:
1. Ages < 18 or > 75 years old
2. Fitzpatrick Skin Phototypes I-IV
3. Known history of allergies or irritant contact dermatitis in response to general skin
care products, including Hydroquinone and Retinol
4. Known allergies or irritant contact dermatitis in response to common ingredients of
physical sunscreen, including but not limited to Zinc Oxide
5. Known allergies or irritant contact dermatitis to topical anesthetics, including
Benzocaine and Tetracaine.
6. Active local or systemic disorders that may affect wound healing or integrity of the
integumentary system
7. History of active or inactive systemic granulomatous disease, (e.g., Sarcoidosis,
Tuberculosis, Granulomatosis with Polyangiitis, etc.), or connective tissue disorders
(e.g., Systemic Lupus Erythematosus, Dermatomyositis, Scleroderma, etc.)
8. Recent history of surgery or significant trauma to the area(s) to be treated
9. Significant scarring (excluding acne scars) in the area(s) to be treated
10. Current or history of hypertrophic scarring or keloid scars
11. Severe or cystic and clinically active acne on the area(s) to be treated
12. Tattoos in the area(s) to be treated
13. Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be
treated and/or have a history of skin cancer
14. Individuals with skin pathology and/or pre-existing dermatologic condition in the
treatment area (i.e., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo,
hyper or hypo-skin pigmentation conditions such as post inflammatory
hyperpigmentation) that the Investigator deems inappropriate for participation or
could interfere with outcomes of the study.
15. History of chronic drug or alcohol use.
16. Microdermabrasion or glycolic acid treatment to the treatment area(s) within 4 weeks
of study participation or who plan on having this treatment during the study.
17. History of the following cosmetic treatments in the area(s) to be treated:
- Injectable filler of any type within the past 2 weeks
- Neurotoxins within the past week
- Ablative resurfacing laser treatment within the past 6 months
- Non-ablative, rejuvenating laser or light treatment within the past 6 months
- Chemical peel or dermabrasion within the past 3 months
18. Individuals undergoing concurrent therapy that, in the Investigator's opinion, would
interfere with the evaluation of the safety or efficacy of the study devices:
• Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use),
and/or
19. Psychiatric drugs that, in the Investigator's opinion, would impair the subject from
understanding protocol requirements or understanding and signing consent.
20. Individuals who are pregnant or nursing or those planning on becoming pregnant during
the study according to self-report.
21. Immunocompromised individuals or those currently using immunosuppressive medications
and/or radiation.
22. Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism,
medically significant hypertension, or hypothyroidism. Those with multiple health
conditions may still be excluded from participation even if conditions are controlled.
23. Individuals with any planned surgeries, overnight hospitalization, and/or invasive
medical procedures planned during the study.
24. Individuals who, in the Investigator's opinion, have a history of poor cooperation,
unreliability or noncompliance with medical treatment.
25. Individuals who are unable to understand instructions or give informed consent
26. Individuals who have physical or psychological conditions which, in the opinion of the
Investigator, makes them unable to complete the study per protocol (e.g., not likely
to avoid other cosmetic treatments to area; not likely to stay in study for entire
duration due to other commitments; or those with concomitant conditions that may
develop symptoms that might confuse or confound study treatments or assessments).
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