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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of laser treatments for women with female pattern hair loss, which typically affects the front or top of the scalp. The study compares a 1550nm non-ablative fractional laser with a 1927nm thulium fractional laser to determine which is more effective. Women with noticeable hair thinning on the front or top of their scalp who haven't used hair growth treatments in the last 6 months may be suitable for this trial. Participants will undergo four laser treatment sessions, each spaced four weeks apart. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for hair loss.

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.

What prior data suggests that these laser treatments are safe for female pattern hair loss?

Research has shown that both the 1550nm and 1927nm laser treatments are generally safe for treating hair loss.

The 1550nm laser effectively treats androgenetic alopecia, a common type of hair loss, with patients experiencing good results and few side effects.

Similarly, studies have demonstrated the safety of the 1927nm laser, which works well without causing major side effects.

Both treatments have undergone safety research and are well-tolerated by patients, making them promising options for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using the 1550nm non-ablative fractional laser and the 1927nm thulium fractional laser for treating androgenetic alopecia because these lasers offer a novel approach compared to traditional treatments like minoxidil or finasteride. Unlike topical solutions or oral medications that can take months to show results, these lasers work by stimulating hair follicles directly through controlled laser energy, potentially providing faster results. Additionally, these treatments are non-invasive and don't require ongoing application of chemicals, making them appealing for those who prefer alternatives to daily medications.

What evidence suggests that this trial's treatments could be effective for female pattern hair loss?

This trial will compare two laser treatments for androgenetic alopecia. Research has shown that the 1550nm non-ablative fractional laser, used for participants in Group A, can effectively treat hair loss. Studies have found it increases hair density, thickness, and regrowth rate. It is known for its safety and often outperforms some traditional treatments.

Meanwhile, the 1927nm thulium fractional laser, used for participants in Group B, has also shown promise. Research indicates it significantly boosts hair density and thickness after several sessions. This laser is safe and leads to noticeable improvements in hair health.

Both lasers offer new hope for those experiencing female pattern hair loss, with evidence supporting their effectiveness in promoting hair growth. ^{1 2 3 4 5}

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. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16459

Progress of clinical research on fractional laser treatment ... Fractional laser treatment of AGA showed remarkable efficacy and high safety. Compared with traditional treatments, fractional laser has the advantages of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11023987/

Lasers in the management of alopecia: a review ... The study defined a positive response as over 50% of hair regrowth in the patch and found that 47% of patients who received the excimer laser ...

3. jddonline.com jddonline.com/articles/evaluating-the-efficacy-of-platelet-rich-plasma-and-1550-nm-fractional-laser-in-combination-and-alone-for-the-management-of-androgenetic-alopecia-S1545961622P1166X/

Evaluating the Efficacy of Platelet Rich Plasma and 1550 ... The 1550 nm factional erbium-glass laser promotes increases in hair density, hair thickness, anagen: telogen ratio, and the rate of hair regrowth. Appropriate ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06926023

NCT06926023 | 1550nm Non-ablative Fractional Vs ... 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 ( ...

5. pdfs.semanticscholar.org pdfs.semanticscholar.org/4b8e/9e3886668b0b10df555a98d7713a2f025577.pdf?skipShowableCheck=true

blinded, controlled, and randomized comparative study on ... Conclusions: Our data demonstrate that 1565 nm NAFL exhibits superior clinical ef- ficacy in some aspects of hair growth to the topical minoxidil. It is a safe ...