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

NCT05493280 | Completed Results FDA Device

• 1 other identifier: STU-2022-0672
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation

Outcome Measures

Primary Outcomes (18)

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

  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.

  Baseline, 1 Month and 3 Months

• Change in Spots - Front of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• Change in Spots- Left Side of Face (Part 1)

  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.

  Baseline, 1 Month and 3 Months

• Change in Spots- Left Side of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• Change in Spots- Right Side of Face (Part 1)

  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.

  Baseline, 1 Month and 3 Months

• Change in Spots- Right Side of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• Change in UV Spots- Front of Face (Part 1)

  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.

  Baseline, 1 Month and 3 Months

• Change in UV Spots- Front of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• Change in UV Spots- Left of Face (Part 1)

  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.

  Baseline, 1 Month and 3 Months

• Change in UV Spots- Left of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• Change in UV Spots- Right Side if Face (Part 1)

  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.

  Baseline, 1 Month and 3 Months

• Change in UV Spots- Right Side if Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• 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.

  Baseline, 1 Month and 3 Months

• Change in Brown Spots- Front of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• Change in Brown Spots- Left of Face (Part 1)

  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.

  Baseline, 1 Month and 3 Months

• Change in Brown Spots- Left of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

• Change in Brown Spots- Right Side of Face (Part 1)

  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.

  Baseline, 1 Month and 3 Months

• Change in Brown Spots- Right Side of Face (Part 2)

  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.

  Baseline, 1 Month and 3 Months

Study Arms (2)

Healthy Participants- Pre-Ttreatment Only

OTHER

Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study. Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care.

Device: MOXI

Healthy Participants- Post-Treatment Only

OTHER

Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study. Subjects will wash out of any topical medications and will receive treatment. Post-treatment care will include use of temovate for 4 days.

Device: MOXI

Interventions

MOXI DEVICE

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

Healthy Participants- Post-Treatment Only; Healthy Participants- Pre-Ttreatment Only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center- Dept of Plastic Surgery

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Lead Coordinator
• Organization: UT Southwestern

jennifer.barillas@utsouthwestern.edu

214-645-8907

Study Officials

• Jeffrey Kenkel, MD

  UT Southwestern- Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 9, 2022
• Study Start: November 14, 2022
• Primary Completion: July 26, 2024
• Study Completion: December 31, 2024
• Last Updated: December 15, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)