Fractional Photothermolysis for Alopecia

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Irvine

Must not be taking: Minoxidil, PRP, Finasteride, others

Disqualifiers: Neoplasm, Infection, Inflammatory disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests laser treatments to help regrow hair in individuals with scalp alopecia (hair loss) at the forehead hairline. It compares two types of lasers, Fraxel DUAL 1550 and Halo by Sciton, to determine which better stimulates hair growth. Participants will receive laser treatment on one side of their head, while the other side remains untreated for comparison. Individuals diagnosed with hair loss who have not used other hair regrowth treatments in the last month may be suitable for this study. As an Early Phase 1 trial, this research aims to understand how these laser treatments work, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial requires that you do not use minoxidil/Rogaine, platelet-rich plasma (PRP), or light devices for hair regrowth during the study. You also should not have started using finasteride/Propecia or spironolactone in the 3 months before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fractional lasers, such as the Fraxel DUAL 1550 and Halo, are generally safe and effective for treating skin and hair issues. Studies have found that the Fraxel DUAL 1550 laser safely promotes hair growth and works well for various types of hair loss. People usually tolerate it well, experiencing only minor side effects.

The Halo laser is also used safely for various skin problems. Known for its gentle approach, it has shown good results in treating hair loss. These lasers typically cause only slight discomfort, and any skin reactions usually heal quickly.

Both lasers are non-ablative, meaning they don't remove the top layer of skin. Instead, they work below the surface, reducing the risk of serious side effects. Although specific safety data for using these lasers on hair loss may be limited, they are already used safely for similar conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using fractional photothermolysis for alopecia because it represents a novel approach compared to traditional treatments like minoxidil or finasteride, which primarily focus on stimulating hair follicles chemically or hormonally. This technique uses lasers, specifically the Fraxel Dual and Halo lasers, to create microscopic thermal zones in the scalp, promoting hair regrowth by harnessing the body's natural healing processes. The dynamic thermal optimization technology of the Halo laser and the precise energy delivery of the Fraxel Dual laser offer a targeted and potentially effective method for encouraging hair growth, which could provide new hope for those struggling with hair loss.

What evidence suggests that fractional photothermolysis might be an effective treatment for alopecia?

This trial will compare the effectiveness of two laser treatments for hair regrowth in patients with alopecia. Research has shown that certain laser treatments, such as the Fraxel DUAL 1550 and Halo lasers, might aid hair growth. Participants in this trial will be assigned to either the Fraxel DUAL 1550 laser group or the Halo laser group. Studies on the Fraxel DUAL 1550 laser found that it can increase the number and thickness of hairs and speed up hair regrowth. Reviews of the Halo laser suggest it can effectively address hair loss in both men and women. Both lasers work by sending heat into the skin to stimulate hair follicles and support hair regrowth. Early findings suggest these methods could be promising for treating hair loss on the scalp, especially near the front hairline. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 18 to 90 with alopecia on the scalp, specifically at the frontal hairline. Participants should be in good health, have not received other hair loss treatments in the past month, and must commit to following the study protocol. Those with a healthy scalp without tumors are eligible; both scarring and non-scarring alopecia are acceptable.

Inclusion Criteria

My scalp is healthy and cancer-free.

I have hair loss, with or without scarring.

Good health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional photothermolysis treatment using either Fraxel DUAL 1550 or Halo by Sciton for hair follicle induction

12 weeks

6-10 visits (in-person) at 2-4 week intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hair regrowth impact on quality of life

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fractional Photothermolysis
• Fraxel Dual laser
• Halo laser

Trial Overview The study tests fractional photothermolysis (laser resurfacing) using two types of lasers: Fraxel DUAL 1550 or Halo by Sciton. It aims to stimulate hair growth through skin rejuvenation. Fifty subjects will receive treatment up to ten times over several weeks, with one side of their head treated and the other as control.

How Is the Trial Designed?

Group I: Halo Hybrid Laser 1550 nm Experimental Treatment 1 Intervention

The Halo laser will be used per protocol due to the dynamic thermal optimization technology for hair regrowth. 25 patients with alopecia will be part of this group.

Group II: Fraxel DUAL 1550 nm Experimental Treatment 1 Intervention

The Fraxel DUAL 1550 nm laser will be used at 7 mJ, 8 pulses, 120 spots/cm2, treatment level 3 (9% coverage) for hair regrowth. 25 patients with alopecia will be part of this group.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Beckman Laser Institute

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

Fractional photothermolysis using the Fraxel laser effectively improves skin color and texture, reduces fine wrinkles, and decreases unwanted pigmentation with minimal downtime for patients, as demonstrated in a study of 70 patients undergoing 2 to 6 treatments.

Patients experienced only mild side effects like redness and swelling for a few days, followed by light skin exfoliation, indicating a safe and well-tolerated procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fraxel skin resurfacing. Collawn, SS.[2007]

Fractional photothermolysis (FPT) using a 1550 nm non-ablative erbium laser effectively treated a depressed facial scar in a 49-year-old woman, making it nearly imperceptible after five treatments over 20 weeks.

This case suggests that FPT may be a promising option for improving scars resulting from Mohs micrographic surgery, with lasting results observed 18 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional photothermolysis improves a depressed alar scar following Mohs micrographic surgery. Schulz, KK., Walling, HW.[2015]

Combining laser treatments (like 308-nm excimer laser and He-Ne laser) with topical minoxidil significantly reduces the Severity of Alopecia Tool (SALT) score, indicating improved efficacy in treating alopecia areata compared to using minoxidil alone, based on a meta-analysis of 10 studies.

The combination therapy also results in a lower recurrence rate of hair loss after one year compared to minoxidil alone, while showing no significant increase in adverse events, suggesting it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser and light therapy combined with topical minoxidil for alopecia areata: a systematic review and meta-analysis of randomized controlled trials. Zhang, J., Lin, P., Lin, H., et al.[2023]

Citations

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

Lasers in the management of alopecia: a review ... The entire scalp hair loss group demonstrated a similar trend, with 20% achieving an excellent response and 40% experiencing a poor response.

2. 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 ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7008732/

The Effect of the Fractional Carbon Dioxide Laser on ... Fractional laser therapy has been introduced to treat AGA as it is a treatment for alopecia and can also prevent hair loss recurrence. Fractional lasers can ...

5. pdfs.semanticscholar.org pdfs.semanticscholar.org/5ad2/f82da6e24a7feeac96054160f7073aa6654d.pdf

Androgenetic alopecia treatment: associating 1550nm ... The present study's objective was to evaluate the associ- ation of laser therapy with injection of active principles in the scalp using mesotherapy, aimed at ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36342732/

Evaluating the Efficacy of Platelet Rich Plasma and 1550 ... All patients experienced improvement in AGA, but patients treated with the combination therapy had greater improvement in hair density. Overall, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03284021

Study Details | NCT03284021 | Fraxel Laser for Alopecia This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living ...