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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hyperpigmentation

Intervention / Treatment
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* Device: MOXI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male, female, and non-binary adults between 18 and 75 years of age Fitzpatrick Skin Phototype V and VI Individuals deemed by the Investigator to have clinically significant hyperpigmentation on their face and desire treatment and correction of this condition Individuals willing to withhold aesthetic therapies (excluding those explicitly prescribed by the Investigator as pre-treatment) for the duration of the study 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 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. Individuals who can read, speak, write, and understand English and who are willing to provide written informed consent. Individuals willing to sign a photography release. 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: Ages < 18 or > 75 years old Fitzpatrick Skin Phototypes I-IV Known history of allergies or irritant contact dermatitis in response to general skin care products, including Hydroquinone and Retinol Known allergies or irritant contact dermatitis in response to common ingredients of physical sunscreen, including but not limited to Zinc Oxide Known allergies or irritant contact dermatitis to topical anesthetics, including Benzocaine and Tetracaine. Active local or systemic disorders that may affect wound healing or integrity of the integumentary system 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.) Recent history of surgery or significant trauma to the area(s) to be treated Significant scarring (excluding acne scars) in the area(s) to be treated Current or history of hypertrophic scarring or keloid scars Severe or cystic and clinically active acne on the area(s) to be treated Tattoos in the area(s) to be treated Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be treated and/or have a history of skin cancer 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. History of chronic drug or alcohol use. 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. 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 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 Psychiatric drugs that, in the Investigator's opinion, would impair the subject from understanding protocol requirements or understanding and signing consent. Individuals who are pregnant or nursing or those planning on becoming pregnant during the study according to self-report. Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation. 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. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the study. Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment. Individuals who are unable to understand instructions or give informed consent 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Participants<br>Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study | Device: MOXI<br>* Patients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of change in overall facial hyperpigmentation in response to laser treatment. | Quantitively assessment of change in overall facial hyperpigmentation using measurements provided VISIA 3D analysis. | Baseline, 1 Month and 3 Months | 
| Change in brown spots and pigmentation from baseline in response to laser treatment at 1 month | Quantitatively assessment from baseline of improvement in overall facial hyperpigmentation using measurements provided VISIA 3D analysis at 1 month | Baseline and 1 month | 
| Change in brown spots and pigmentation from baseline in response to laser treatment at 3 months | Quantitatively assessment from baseline of change in overall facial hyperpigmentation using measurements provided VISIA 3D analysis at 3 months | Baseline and 3 months | 
| Change in Skin Hyperpigmentation Index (SHI) Scores from baseline at 1 month | SHI software will calculate the relative contribution of pigmentation of each pixel to create a score, and a coefficient is the derived from comparing pigmentation scores of the area with hyperpigmentation versus the reference point. The SHI ranges from 1 (no hyperpigmentation) to 4 (maximum hyperpigmentation). | Baseline and 1 month | 
| Change in Skin Hyperpigmentation Index (SHI) Scores from baseline at 3 months | SHI software will calculate the relative contribution of pigmentation of each pixel to create a score, and a coefficient is the derived from comparing pigmentation scores of the area with hyperpigmentation versus the reference point. The SHI ranges from 1 (no hyperpigmentation) to 4 (maximum hyperpigmentation). | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The study team will monitor incidence, severity, and relatedness of adverse events throughout the study. | Through study completion, an average of 7 months | 
| Participant response to pre-post treatment regimens | Study team will monitor incidence of postinflammatory hyperpigmentation after treatment. Subjects will begin topical regimen before first treatment and resume 7 days post final treatment to avoid hyperpigmentation after treatment. | Through study completion, an average of 10 months |