Lily Device for Hair Loss

(PREVAIL Trial)

Recruiting at 4 trial locations

Overseen By Kimberly Wilkinson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Luminate Medical, Inc.

Must not be taking: Hormone therapy, Anti-estrogen therapy

Disqualifiers: Alopecia, Autoimmune disease, Brain irradiation, others

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

Compensation: Varies

Number of Visits: 34

85 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on hormone replacement therapy or anti-estrogen therapy that causes hair loss, you may not be eligible to participate.

What data supports the effectiveness of the Lily Device treatment for hair loss?

Research shows that low-level laser therapy (LLLT), similar to the Lily Device, is effective in promoting hair growth for androgenetic alopecia (a common form of hair loss) in both men and women. Studies have found that LLLT devices can increase hair density and diameter with minimal side effects. ^{1 2 3 4 5}

Is the Lily Device for Hair Loss safe for use in humans?

Photobiomodulation devices, like the Lily Device, have an excellent safety profile with few significant adverse events reported in studies. They are considered safe for home use, and several trials have shown they are generally safe for treating hair loss. ^{2 4 6 7 8}

How does the Lily Device treatment for hair loss differ from other treatments?

The Lily Device for hair loss is unique because it likely uses photobiomodulation (low-level laser therapy) to stimulate hair growth, similar to devices like the HairMax LaserComb. This method involves using light to promote healing and hair growth, offering a non-invasive and potentially effective alternative to traditional hair loss treatments. ^{2 3 4 7 8}

What is the purpose of this trial?

The goal of this clinical trial is to test if the Lily Device works to reduce chemotherapy induced hair loss in patients. It will also learn about the safety of the Lily Device. The main questions it aims to answer is: * Do patient preserve their hair using the Lily Device after 4 cycles of chemotherapy, when hair preservation is a Grade ≤1 graded by an independent healthcare professional on the Common Terminology Criteria for Adverse Events (CTCAE)? * What is the subject incidence of Grade 1 or above Adverse Device Events (ADE's)?

Eligibility Criteria

This trial is for individuals experiencing hair loss due to chemotherapy. Participants should be undergoing chemo and interested in trying the Lily Device, a new tool aimed at reducing hair loss. Specific eligibility details are not provided, but typically include being of a certain age and health status.

Inclusion Criteria

Participants who experience a hypersensitivity reaction to chemotherapy are allowed to continue in the study if the standard doses are maintained

Head size within the specified study sizing range

Participants on the chemotherapy plan KEYNOTE-522 are eligible for this study

Exclusion Criteria

I lost my hair due to chemotherapy in the last 2 years.

I have had issues with my jaw joint.

Use of hair loss reduction devices during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy treatment while using the Lily Device to test its efficacy in reducing hair loss

8-12 weeks

4 cycles of chemotherapy, each cycle is 14-21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of hair preservation and adverse device events

4 weeks

End of study visit 30 days after the last treatment visit

Treatment Details

Interventions

• Lily Device

Trial Overview The study tests the effectiveness of the Lily Device in preventing hair loss from chemotherapy over four treatment cycles. It also assesses safety by monitoring Adverse Device Events (ADEs). Success is measured by whether patients keep most of their hair according to a professional grading scale.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Luminate Medical, Inc.

Lead Sponsor

Trials

1

Recruited

90+

Findings from Research

The RAMACAP helmet-type low-level laser therapy (LLLT) device significantly improved hair density and diameter in patients with androgenetic alopecia after 24 weeks of treatment, outperforming a sham device in a study of 40 participants.

The treatment was generally safe, with only minor side effects like temporary hair shedding and scalp itching reported, indicating that it could be a viable option for both men and women suffering from hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial. Suchonwanit, P., Chalermroj, N., Khunkhet, S.[2020]

Photobiomodulation, or low-level laser therapy, is a safe and potentially effective treatment for hair loss, supported by several randomized trials.

Devices for this therapy, such as LED caps or helmets, are user-friendly and can be used at home, although there are limitations like cost and the need for managing patient expectations regarding results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation for the management of hair loss. Torres, AE., Lim, HW.[2021]

A survey of 60 participants revealed that efficacy is the most important factor for users when selecting a photobiomodulation device for hair loss, with 67.8% prioritizing this aspect.

Most respondents preferred a hands-free device and reasonable treatment durations of 15 to 20 minutes, indicating user preferences that could guide future device design and marketing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and alopecia: a crowdsourced survey study on patient preferences. Paiewonsky, B., Winter, M., Hordinsky, M., et al.[2023]

Thirteen FDA-cleared home-use photobiomodulation devices for treating androgenetic alopecia were identified, showing a variety of designs and features, but no direct comparisons of their efficacy exist.

These devices have an excellent safety profile and growing evidence of effectiveness, although more long-term studies are needed to confirm their efficacy across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration. Dodd, EM., Winter, MA., Hordinsky, MK., et al.[2018]

A computer-aided imaging system (CAIS) was developed to provide a quantitative assessment of baldness in 38 Chinese women with female pattern hair loss (FPHL), showing an average central balding area (CBA) of 9,391.12 mm.

The CAIS measurements correlated well with traditional clinical staging methods, suggesting it can enhance the accuracy and efficiency of evaluating the severity of FPHL compared to subjective visual assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Evaluation of Female Pattern Hair Loss in Chinese Women: A Preliminary Study. Hung, PK., Tsai, J., Chen, CM., et al.[2022]

A systematic review of 37 clinical trials found that home-based devices like intense pulsed light and laser diodes are effective for treating conditions such as hair removal and androgenic alopecia, respectively.

All evaluated devices demonstrated favorable safety profiles with minimal significant adverse events, although there is limited long-term data on their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based devices in dermatology: a systematic review of safety and efficacy. Cohen, M., Austin, E., Masub, N., et al.[2022]

In a 26-week double-blind study involving 110 male patients with androgenetic alopecia, the HairMax LaserComb significantly increased hair density compared to a sham device, indicating its effectiveness in promoting hair growth.

The HairMax LaserComb was well tolerated with no serious adverse events reported, suggesting it is a safe option for treating hair loss in males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Leavitt, M., Charles, G., Heyman, E., et al.[2021]

LED-based devices are emerging as safe and effective tools for treating various skin and hair disorders, including inflammation and aging.

Despite their growing use in dermatology, more controlled studies are necessary to further confirm the efficacy of LED therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. Sorbellini, E., Rucco, M., Rinaldi, F.[2019]

References

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

Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial. [2020]

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

Photobiomodulation for the management of hair loss. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation and alopecia: a crowdsourced survey study on patient preferences. [2023]

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

Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration. [2018]

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

Quantitative Evaluation of Female Pattern Hair Loss in Chinese Women: A Preliminary Study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Home-based devices in dermatology: a systematic review of safety and efficacy. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. [2021]

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

Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. [2019]