Fractionated 1927nm Laser for Hyperpigmentation in Fitzpatrick Skin Phototypes V and VI

Quantifying Hyperpigmentation Response to Fractionated 1927nm in Fitzpatrick Skin Phototype V and VI: A Pilot Study

The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.

This single-center clinical trial is being conducted over the course of 7 months, including one Initial Screening Visit (-42 to -28 Days) and three treatments (Day 0, Day 30, Day 60) followed by 1-month and 3-month follow-up visits (Day 90 and Day 120). The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.

The Investigators will explore this question with a non-blinded, pilot study at a single center.

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).