Laser Treatments for Androgenetic Alopecia

Overseen By Andrea Pacheco

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Must not be taking: Immunosuppressants, Anticoagulants, Minoxidil, others

Disqualifiers: Thyroid disease, Autoimmune disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires that you stop using any hair growth treatments or procedures, including certain medications and supplements, for at least 6 months before joining. If you're on medications affecting hair growth, you may need to stop them to participate.

Is laser treatment for androgenetic alopecia safe?

Research shows that laser treatments like the 1927-nm thulium laser and erbium-glass laser are generally safe for treating hair loss, with no significant side effects reported in studies. ^{1 2 3 4 5}

How is the 1550nm Non-ablative Fractional Laser and 1927nm Thulium Fractional Laser treatment different from other treatments for androgenetic alopecia?

This treatment uses specific types of lasers to help improve hair thickness by enhancing the penetration of topical medications and stimulating hair follicles, which is different from traditional treatments like minoxidil that are applied directly to the scalp without laser assistance. The use of lasers can also rejuvenate the scalp and improve hair shaft diameter, offering a novel approach compared to standard topical or oral treatments. ^{1 2 3 6 7}

What data supports the effectiveness of the 1550nm Non-ablative Fractional Laser and 1927nm Thulium Fractional Laser treatment for androgenetic alopecia?

Research shows that fractional lasers, like the 1927nm thulium laser, can significantly increase hair density and thickness in people with pattern hair loss. Additionally, studies indicate that fractional laser treatments can improve hair shaft diameter, suggesting they may be effective for hair regrowth. ^{1 2 4 5 8}

Are You a Good Fit for This Trial?

This trial is for adult women aged 35-65 with female pattern hair loss, who have not used any hair growth treatments in the last 6 months. Participants must be in good health, agree to dye gray hair for consistency, and use effective birth control if of childbearing potential. Exclusions include bleeding disorders, certain medical conditions like connective tissue disease or thyroid issues, smoking, pregnancy, and recent participation in other research studies.

Inclusion Criteria

I am a woman aged between 35 and 65.

Fitzpatrick skin types I-IV

I have female pattern hair loss on the top or front of my scalp.

Exclusion Criteria

I have a history of bleeding disorders, use anticoagulants, or have connective tissue disease, Bell's Palsy, epilepsy; I smoke, am pregnant or breastfeeding.

Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study

I do not have skin conditions, metal implants, or infections in the treatment area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either the 1550nm non-ablative fractional laser or the 1927nm thulium fractional laser treatment, with a total of 4 treatments spaced 4 weeks apart

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Day 180

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 1550nm Non-ablative Fractional Laser
• 1927nm Thulium Fractional Laser

Trial Overview The study tests the effectiveness of two types of lasers: a 1550nm non-ablative fractional laser and a 1927nm thulium fractional laser on treating female pattern hair loss. Women will receive one of these laser treatments to see which is more effective.

How Is the Trial Designed?

Group I: GROUP A 1550nm non-ablative fractional laser Experimental Treatment 1 Intervention

Group A: Study subjects will have a total of 4 treatments spaced 4 weeks apart. No additional topical treatments applied

Group II: GROUP B 1927 thulium fractional laser Active Control 1 Intervention

Group B: Study subjects will have a total of 4 treatments spaced 4 weeks apart. No additional topical treatments applied.

Who Is Running the Clinical Trial?

Goldman, Butterwick, Fitzpatrick and Groff

Lead Sponsor

Trials

32

Recruited

660+

Published Research Related to This Trial

A single treatment session with the 1,927 nm thulium fiber laser resulted in a 60-90% improvement in scalp photodamage, including dyspigmentation, solar lentigines, and keratosis in four male patients.

The procedure was safe, with no adverse events reported, indicating that this laser treatment is well-tolerated and effective for rejuvenating the male scalp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rejuvenation of the male scalp using 1,927 nm non-ablative fractional thulium fiber laser. Boen, M., Wilson, MJV., Goldman, MP., et al.[2022]

A pilot study involving males aged 20 to 60 with androgenic alopecia showed a statistically significant increase in hair growth after using the cold X5 hairlaser device over a 26-week period, with a strong p-value of 0.0003 indicating effectiveness.

The study demonstrated a consistent positive trend in hair counts over time, suggesting that the X5 hairlaser device may be a promising treatment for male pattern hair loss, although further research is needed due to some limitations in the control group data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Cold" X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study. Blum, K., Han, D., Madigan, MA., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Fractional non-ablative laser-assisted drug delivery leads to improvement in male and female pattern hair loss. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

The Effect of the Fractional Carbon Dioxide Laser on Improving Minoxidil Delivery for the Treatment of Androgenetic Alopecia. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Use of fractionated laser therapy for the treatment of androgenetic alopecia: a systematic review and meta-analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy and safety of a 1927-nm fractionated thulium laser on pattern hair loss: an evaluator-blinded, split-scalp study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Rejuvenation of the male scalp using 1,927 nm non-ablative fractional thulium fiber laser. [2022]

7. England pubmed.ncbi.nlm.nih.gov

"Cold" X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Topical 5% minoxidil versus combined erbium YAG laser and topical 5% minoxidil in androgenetic alopecia: A randomized controlled trial. [2023]