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
Goldman, Butterwick, Fitzpatrick and Groff
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).
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…
Eligibility
- Age range
- 35–65 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Adult women aged 35-65 years 2. Fitzpatrick skin types I-IV 3. Presence of female pattern hair loss of the frontal or vertex of scalp (Sinclair (II-IV) 4. 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 5. Patients with gray hair roots must be willing to dye their gray hair within two weeks of the first appointment and the last 3-month follow-up visit to ensure consistency in evaluator assessments. 6. No use of hair gr…
Interventions
- Device1550nm non-ablative fractional laser
Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.
- Device1927 thulium fractional laser
Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.
Location
- West Dermatology Research Center/Cosmetic Laser DermatologySan Diego, California