Female Pattern BaldnessNCT06926023
1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss
A study testing 1550nm non-ablative fractional laser and 1927 thulium fractional laser in people with Female Pattern Baldness, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Pattern Baldness
- What is being tested?
- 1550nm non-ablative fractional laser and 1927 thulium fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: 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
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).
Read the 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
- Conditions
- Female Pattern Baldness
- Being tested
- 1550nm non-ablative fractional laser, 1927 thulium fractional laser
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1550nm non-ablative fractional laserDevice
Treatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp.
1927 thulium fractional laserDevice
Treatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: 1550nm non-ablative fractional laser |
| 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. Receives: Device: 1927 thulium fractional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hair count at a predefined 1cm x 1cm scalp location
Measured by the Canfield Hair Matrix System
Measured: Baseline and Day 180
Change in hair density (hairs/cm) at the same predefined scalp area
Measured by the Canfield Hair Matrix System
Measured: Baseline and Day 180
Change in terminal hair average diameter (in mm) at the predefined location
Measured by the Canfield Hair Matrix System
Measured: Baseline and Day 180
Secondary outcomes (5)
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)
Measured: Baseline and Day 180
Change in perceived age based on blinded evaluator assessment of global scalp photographs
Estimated age based on posterior scalp evaluation
Visit Perceived Age (years)
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Day 30, Day 60, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern BaldnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926023
- Sponsor's protocol ID
- Hair-1550-vs-1927
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06926023
- Acronym / sponsor ID
- Hair-1550-vs-1927
- Conditions
- Female Pattern Baldness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A 1550nm non-ablative fractional laser | Experimental | Device: 1550nm non-ablative fractional laserGroup 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 | Device: 1927 thulium fractional laserGroup B: Study subjects will have a total of 4 treatments spaced 4 weeks apart. No additional topical treatments applied. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1550nm non-ablative fractional laserTreatment with the 1550nm non-ablative fractional laser for female pattern hair loss to the frontal and crown of scalp. | Device | GROUP A 1550nm non-ablative fractional laser |
| 1927 thulium fractional laserTreatment with the 1927 thulium fractional laser for female pattern hair loss to the frontal and crown of scalp. | Device | GROUP B 1927 thulium fractional laser |
Primary outcome
Change in hair count at a predefined 1cm x 1cm scalp location
Time frame: Baseline and Day 180
Measured by the Canfield Hair Matrix System
Change in hair density (hairs/cm) at the same predefined scalp area
Time frame: Baseline and Day 180
Measured by the Canfield Hair Matrix System
Change in terminal hair average diameter (in mm) at the predefined location
Time frame: Baseline and Day 180
Measured by the Canfield Hair Matrix System
5 secondary outcomes
Change in Sinclair Scale score
Time frame: Baseline and Day 180
Change in perceived age based on blinded evaluator assessment of global scalp photographs
Time frame: Baseline and Day 180
Subjective Assessment on Hair outcomes
Time frame: Day 180
Physician Global Aesthetic Improvement Scale (PGAIS) via photos by blinded evaluator
Time frame: Day 180
Comfort Level Visual Analog Scale
Time frame: Baseline, Day 30, Day 60, Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1550nm non-ablative fractional laser and 1927 thulium fractional laser in people with Female Pattern Baldness, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (858-657-1004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hair count at a predefined 1cm x 1cm scalp location (time frame: Baseline and Day 180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.