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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A 1550nm non-ablative fractional laser | Experimental | Group A: Study subjects will have a total of 4 treatments spaced 4 weeks apart. No additional topical treatments applied |
|
| GROUP B 1927 thulium fractional laser | Active Comparator | Group B: Study subjects will have a total of 4 treatments spaced 4 weeks apart. No additional topical treatments applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1550nm non-ablative fractional laser | Device | Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hair count at a predefined 1cm x 1cm scalp location | Measured by the Canfield Hair Matrix System | Baseline and Day 180 |
| Change in hair density (hairs/cm) at the same predefined scalp area | Measured by the Canfield Hair Matrix System | Baseline and Day 180 |
| Change in terminal hair average diameter (in mm) at the predefined location | Measured by the Canfield Hair Matrix System | Baseline and Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and Day 180 |
| Change in perceived age based on blinded evaluator assessment of global scalp photographs |
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Inclusion Criteria:
Exclusion Criteria:
Gender Identity
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 858-657-1004 | apacheco@clderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center/Cosmetic Laser Dermatology | San Diego | California | 92121 | United States |
undecided
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Evaluator Blind
| 1927 thulium fractional laser | Device | Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp. |
|
Estimated age based on posterior scalp evaluation Visit Perceived Age (years) |
| 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 | 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 | Day 180 |
| Comfort Level Visual Analog Scale | 0 No Pain 1-3 Mild 4-6 Moderate to Severe 7-9 Very Severe 10 Worst Pain Possible | Baseline, Day 30, Day 60, Day 90 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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