Not Yet RecruitingNot Applicable

1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss

United States10 participantsStarted 2025-05-01

Plain-language 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).

Who can participate

Age range35 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Change in hair count at a predefined 1cm x 1cm scalp location

Timeframe: Baseline and Day 180

Change in hair density (hairs/cm) at the same predefined scalp area

Timeframe: Baseline and Day 180

Change in terminal hair average diameter (in mm) at the predefined location

Timeframe: Baseline and Day 180

Trial details

NCT IDNCT06926023

SponsorGoldman, Butterwick, Fitzpatrick and Groff

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

Contact for this trial

Andrea Pacheco

858-657-1004 apacheco@clderm.com

View on ClinicalTrials.gov More Female Pattern Baldness trials

Who can participate

Age range35 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.