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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.
Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, United States
Change in hair count at a predefined 1cm x 1cm scalp location
Measured by the Canfield Hair Matrix System
Time frame: Baseline and Day 180
Change in hair density (hairs/cm) at the same predefined scalp area
Measured by the Canfield Hair Matrix System
Time frame: Baseline and Day 180
Change in terminal hair average diameter (in mm) at the predefined location
Measured by the Canfield Hair Matrix System
Time frame: Baseline and Day 180
Change in Sinclair Scale score
Sinclair photo grading scale II-IV Grades 1 thru 5 (system would not allow to paste/insert the photo scale)
Time frame: Baseline and Day 180
Change in perceived age based on blinded evaluator assessment of global scalp photographs
Estimated age based on posterior scalp evaluation Visit Perceived Age (years)
Time frame: Baseline and Day 180
Subjective Assessment on Hair outcomes
Category 1 - No improvement 2 - Slight improvement 3 - Moderate improvement 4 - Noticeable improvement 5 - Significant improvement Hair Density Hair Thickness Hair Growth
Time frame: Day 180
Physician Global Aesthetic Improvement Scale (PGAIS) via photos by blinded evaluator
Description Grade Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2
Time frame: Day 180
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Comfort Level Visual Analog Scale
0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible
Time frame: Baseline, Day 30, Day 60, Day 90