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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to evaluate the effects of fractional photothermolysis (known as laser resurfacing) using fractional laser for the induction of hair follicles via skin rejuvenation in subjects with scalp alopecia (specifically, alopecia on the superior forehead at the frontal hairline). Fractional photothermolysis has been shown to be effective in promoting hair growth. The investigators will study 50 subjects who will be treated 6-10 times at 2-4 week intervals. Each participant will have half of their head treated with a laser, either Fraxel DUAL 1550 or Halo by Sciton, and the other half of their head will be left untreated as a control. Half of the individuals will randomly be assigned to the group to be treated with Fraxel DUAL 1550, and the other half will be treated with Halo by Sciton. Visual observation and digital, photographic, non-invasive imaging will be used to compare the treated and untreated area to assess for differences in hair follicle stimulation rates, number and density of hairs. As noted above, the types of lasers we plan to use include the non-ablative fractional laser settings for the Fraxel DUAL 1550 and Halo by Sciton. A fractional laser is a laser that directs an intense burst of laser energy on the skin. The treatment deposits heat deep into the dermis to tighten skin and stimulate collagen remodeling. The necrotic (death of cells or tissue) injury heals rapidly and adverse effects are few. Laser resurfacing is commonly used for rejuvenation of the skin to improve quality, tone, and texture.

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 Fractional Photothermolysis safe for treating alopecia?

Fractional Photothermolysis, also known as fractional laser treatment, has been used safely in humans for hair loss conditions like androgenetic alopecia, with no significant side effects reported in small studies. However, more high-quality research is needed to fully confirm its safety. ^{1 2 3 4 5}

How does the treatment Fractional Photothermolysis for Alopecia differ from other treatments for hair loss?

Fractional Photothermolysis is unique because it uses a laser to create tiny injuries in the skin, which helps topical medications penetrate better and stimulate hair regrowth. This approach is different from standard treatments as it combines laser technology with topical drugs to enhance their effectiveness. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Fractional Photothermolysis for Alopecia?

Research shows that fractional photothermolysis, when used with topical medications, improved hair regrowth and density in patients with male and female pattern hair loss. Additionally, this laser treatment has been effective in improving skin conditions like wrinkles and pigmentation, suggesting its potential for promoting healing and regeneration. ^{2 7 10 11 12}

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.

I have not experienced any unexpected hair regrowth.

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]

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]

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]

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

Fraxel skin resurfacing. [2007]

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

Fractionated laser skin resurfacing treatment complications: a review. [2022]

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

The Use of a 1,540 nm Fractional Erbium-Glass Laser in Treatment of Alopecia Areata. [2020]

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

Fractional nonablative laser resurfacing: is there a skin tightening effect? [2014]

6. England 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. [2023]

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

Topical minoxidil: review of efficacy and safety. [2013]

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

Axillary hair removal with 1064-nm Nd:YAG laser increases sweat production. [2015]

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

Complications of fractional CO2 laser resurfacing: four cases. [2012]

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

Fractional photothermolysis improves a depressed alar scar following Mohs micrographic surgery. [2015]

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

Review of fractional photothermolysis: treatment indications and efficacy. [2009]

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

Clinical experience with the Fraxel SR laser: 202 treatments in 59 consecutive patients. [2021]