NCT06926023

1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss

A Prospective, Randomized, Evaluator-blind, Clinical Trial Evaluating the 1550nm Non-ablative Fractional or 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy of either a 1550nm non-ablative fractional laser or a 1927nm thulium fractional laser in the treatment of female pattern hair loss (FPHL).

Detailed description

The study will have a total of eight visits, from baseline (Day 0) to the final follow-up at 3 months following the last treatment. The first visit (Visit 1, Day 0) will be for screening. During this visit, informed consent, HIPAA authorization, and a photo release will be obtained from all participants. Investigators will review the inclusion and exclusion criteria, medical history, and any concurrent medications. A urine pregnancy test will be administered for all eligible subjects. Baseline hair loss will be evaluated and standardized 2D photographs will be taken for future comparison. Hair count, hair density, and terminal hair average diameter will be evaluated as a pre-defined scalp location.. Patients will be randomized to groups (Group A or B).Visits 2 through 5 (Day 30, 60, 90, and 120, ± 5 days) will consist of the treatment phase. Participants will be treated based on which treatment group they were randomized too as below

Conditions

• Female Pattern Baldness

Interventions

Type	Name	Description
DEVICE	1550nm non-ablative fractional laser	Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.
DEVICE	1927 thulium fractional laser	Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2025-04-13
• Last updated: 2025-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study