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).
Adult women aged 35-65 years
Fitzpatrick skin types I-IV
Presence of female pattern hair loss of the frontal or vertex of scalp (Sinclair (II-IV)
Must be willing and can comply with all study protocols, including all treatment schedules, follow up visit, assessments, sign a photography release and ICF, and complete the entire course of the study
No surgery, pregnancy, breast feeding, change in or addition of hormonal contraception in the last 6 months
No history of iron deficiency anemia, vitamin D deficiency, or thyroid disease (hypothyroidism or hyperthyroidism or currently on thyroid supplementation)
Use of scalp light or with laser treatment within the last 6 months.
Use of topical or systemic drugs affecting hair growth within 6 months prior to enrollment (such as oral spironolactone, finasteride, oral or topical minoxidil, and supplements marketed for hair growth such as Nutrafol)
Parallel
1550nm non-ablative fractional laser
DeviceTreatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.
1927 thulium fractional laser
DeviceTreatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.
Change in hair count at a predefined 1cm x 1cm scalp location
Measured by the Canfield Hair Matrix System
Change in hair density (hairs/cm) at the same predefined scalp area
Measured by the Canfield Hair Matrix System
Change in terminal hair average diameter (in mm) at the predefined location
Measured by the Canfield Hair Matrix System
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)
Change in perceived age based on blinded evaluator assessment of global scalp photographs
Estimated age based on posterior scalp evaluation Visit Perceived Age (years)
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
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
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