Female Pattern Baldness
Conditions
Brief 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
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.
Sponsors
Goldman, Butterwick, Fitzpatrick and Groff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Evaluator Blind
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
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 growth treatments or procedures within 6 months prior to enrollment (including hair supplements such as Nutrafol) 7. Subjects in good general health based on investigator's judgment and medical history 8. Negative urine pregnancy test result at the time of study entry 9. Subjects will be of non-childbearing potential defined as: 10. Having no uterus 11. No menses for at least 12 months. 12. Or; 13. Subjects of childbearing potential must agree to use an effective method of birth control during the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. Acceptable forms of birth control below: 14. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device 15. Intrauterine coil 16. Bilateral tubal ligation 17. Hysterectomy 18. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom) 19. Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active). 20. Vasectomized (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized partner).
Exclusion criteria
1. No surgery, pregnancy, breast feeding, change in or addition of hormonal contraception in the last 6 months 2. No history of iron deficiency anemia, vitamin D deficiency, or thyroid disease (hypothyroidism or hyperthyroidism or currently on thyroid supplementation) 3. Use of scalp light or with laser treatment within the last 6 months. 4. 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) 5. Supplementation of oral tumeric/curcumin 6. History of hair transplant 7. Systemic or scalp disease that may affect hair growth (Lupus, alopecia areata, folliculitis decalvans, psoriasis, scalp infection, seborrheic dermatitis, CCCA, telogen effluvium) 8. Pregnancy or planned pregnancy during the study or currently breastfeeding. 9. Any uncontrolled systemic disease 10. History of autoimmune connective tissue disease or thyroid disease. 11. Current use of immunosuppressive medication. 12. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. 13. Active dermatitis, metal or other active implants, active infection in the proposed treatment area. 14. Subjects with scarring in the treatment areas (scalp) Subjects with a history of keloids will be excluded. 15. History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease, history of Bell's Palsy, epilepsy, smoking, pregnancy, and lactation. 16. Inability to following the comply with study protocols and regulations 17. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hair count at a predefined 1cm x 1cm scalp location | Baseline and Day 180 | Measured by the Canfield Hair Matrix System |
| Change in hair density (hairs/cm) at the same predefined scalp area | Baseline and Day 180 | Measured by the Canfield Hair Matrix System |
| Change in terminal hair average diameter (in mm) at the predefined location | Baseline and Day 180 | Measured by the Canfield Hair Matrix System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Aesthetic Improvement Scale (PGAIS) via photos by blinded evaluator | Day 180 | Description Grade Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2 |
| Change in Sinclair Scale score | Baseline and Day 180 | Sinclair photo grading scale II-IV Grades 1 thru 5 (system would not allow to paste/insert the photo scale) |
| Comfort Level Visual Analog Scale | Baseline, Day 30, Day 60, Day 90 | 0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible |
| Change in perceived age based on blinded evaluator assessment of global scalp photographs | Baseline and Day 180 | Estimated age based on posterior scalp evaluation Visit Perceived Age (years) |
| Subjective Assessment on Hair outcomes | Day 180 | Category 1 - No improvement 2 - Slight improvement 3 - Moderate improvement 4 - Noticeable improvement 5 - Significant improvement Hair Density Hair Thickness Hair Growth |
Countries
United States
Contacts
Primary ContactAndrea Pacheco
Outcome results
None listed