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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patients will receive treatment using f1927 devices and will be treated over the affected areas, once each month for a total of three months.
UT Southwestern Medical Center- Dept of Plastic Surgery
Dallas, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 Month and 3 Months
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 Month and 3 Months