NCT05493280

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperpigmentation

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-11-14
• Primary completion: 2024-07-26
• Completion: 2024-12-31
• First posted: 2022-08-09
• Last updated: 2025-12-15
• Results posted: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study