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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05493280

Enrollment

Registered

2022-08-09

Start date

2022-11-14

Completion date

2024-12-31

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperpigmentation

Brief summary

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

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.

Interventions

DEVICEMOXI

Patients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Change in Spots - Front of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face Count- the number of individual features detected in the region of interest.
Change in Spots - Front of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of front face Count- the number of individual features detected in the region of interest.
Change in Spots- Left Side of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Spots- Left Side of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Spots- Right Side of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in Spots- Right Side of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Front of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Front of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Left of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Left of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of the face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Right Side if Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in UV Spots- Right Side if Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Front of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Front of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Left of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Left of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of left side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Right Side of Face (Part 1)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.
Change in Brown Spots- Right Side of Face (Part 2)	Baseline, 1 Month and 3 Months	Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of right side of face Count= the number if individual features detected in the region of interest.

Countries

United States

Participant flow

Pre-assignment details

Out of 10 subjects who completed Part 1 (Pre-Treatment Group), only 6 continued to washout and Part 2 portion of this study and thus additional subjects were enrolled in part 2 (Post-Treatment Group) as represented in the data table below.

Participants by arm

Arm	Count
Healthy Subjects: First Pre-Treatment Only(Part 1), Then Post-Treatment Only(Part 2) After Washout Part 1: Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care. Part 2: Care will include use of temovate/ice for 4 days. MOXI: Patients will receive 3 treatments using f1927 devices and will be treated over the affected areas, once each month for a total of three months. F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.	12
Healthy Participants: Part 2 Only Subjects will wash out of any topical medications and will receive 3 treatments. Post-treatment care will include use of temovate/ice for 4 days. MOXI: Patients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months. F1927 nm treatment and energy parameters included a pulse energy of 10 mJ, density of 10% with 10% coverage, and six total passes.	3
Total	15

Withdrawals & dropouts

Period	Reason	FG000	FG001
Part 2 intervention (7 months)	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Healthy Subjects: First Pre-Treatment Only(Part 1), Then Post-Treatment Only(Part 2) After Washout	Healthy Participants: Part 2 Only	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	12 Participants	3 Participants	15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants	1 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	10 Participants	0 Participants	10 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	2 Participants	2 Participants	4 Participants
Region of Enrollment United States	12 participants	3 participants	15 participants
Sex: Female, Male Female	12 Participants	3 Participants	15 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 6	0 / 3
other Total, other adverse events	0 / 12	0 / 6	0 / 3
serious Total, serious adverse events	0 / 12	0 / 6	0 / 3

Outcome results

Primary

Change in Brown Spots- Front of Face (Part 1)

Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis of front of face Count= the number if individual features detected in the region of interest.