Status:
NOT_YET_RECRUITING
1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss
Lead Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Conditions:
Female Pattern Baldness
Eligibility:
FEMALE
35-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
- No use of hair growth treatments or procedures within 6 months prior to enrollment (including hair supplements such as Nutrafol)
- Subjects in good general health based on investigator's judgment and medical history
- Negative urine pregnancy test result at the time of study entry
- Subjects will be of non-childbearing potential defined as:
- Having no uterus
- No menses for at least 12 months.
- Or;
- 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:
- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- Intrauterine coil
- Bilateral tubal ligation
- Hysterectomy
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- Vasectomized (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized partner).
Exclusion
- 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)
- Supplementation of oral tumeric/curcumin
- History of hair transplant
- Systemic or scalp disease that may affect hair growth (Lupus, alopecia areata, folliculitis decalvans, psoriasis, scalp infection, seborrheic dermatitis, CCCA, telogen effluvium)
- Pregnancy or planned pregnancy during the study or currently breastfeeding.
- Any uncontrolled systemic disease
- History of autoimmune connective tissue disease or thyroid disease.
- Current use of immunosuppressive medication.
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Active dermatitis, metal or other active implants, active infection in the proposed treatment area.
- Subjects with scarring in the treatment areas (scalp) Subjects with a history of keloids will be excluded.
- History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease, history of Bell's Palsy, epilepsy, smoking, pregnancy, and lactation.
- Inability to following the comply with study protocols and regulations
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06926023
Start Date
May 1 2025
End Date
December 31 2025
Last Update
April 16 2025
Active Locations (1)
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1
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, United States, 92121