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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Lily Device, to determine if it can prevent hair loss in individuals undergoing chemotherapy for breast cancer. Researchers aim to discover whether it helps patients retain their hair after four rounds of chemotherapy and assess its safety. Ideal participants are adults with stage 1, 2, or 3 breast cancer who have not yet started chemotherapy and plan to complete it within 12 months. As an unphased trial, this study allows patients to contribute to innovative research that could enhance quality of life during chemotherapy.

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 prior data suggests that the Lily Device is safe for reducing chemotherapy-induced hair loss?

Research has shown that the Lily Device is generally safe for treating hair loss and can be used at home without causing serious side effects. However, this trial aims to learn more about its safety for people undergoing chemotherapy. The study will identify any problems caused by the device beyond minor issues. Overall, evidence suggests that the Lily Device is well-tolerated, but this trial will help confirm its safety for chemotherapy patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Lily Device is unique because it uses a non-invasive approach to tackling hair loss, setting it apart from conventional treatments like topical minoxidil or oral finasteride. While most hair loss treatments rely on chemical interventions, the Lily Device employs advanced technology to stimulate hair growth. Researchers are excited about this treatment because it offers a potential alternative for those who might not respond well to or want to avoid the side effects of current medications. Additionally, its novel mechanism could provide faster results without the need for daily application or ingestion.

What evidence suggests that the Lily Device is effective for reducing chemotherapy-induced hair loss?

Research has shown that the Lily Device, which employs localized microvasculature compression therapy, is being tested in this trial to determine its effectiveness in preventing hair loss from chemotherapy. Although specific data on chemotherapy-induced hair loss is limited, similar devices, such as the RAMACAP helmet using low-level laser therapy, have improved hair thickness and growth in conditions like androgenetic alopecia. These early findings suggest that the Lily Device might protect hair during chemotherapy by reducing damage to hair follicles. Overall, devices like these have helped about half of the patients retain 50% or more of their hair. While more detailed research is necessary, this indicates promise for the Lily Device in helping patients maintain their hair during treatment. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

Head size within the specified study sizing range

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

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.

Use of hair loss reduction devices during the study

I have had issues with my jaw joint.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Luminate Medical, Inc.

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06786078

Study Details | NCT06786078 | The Lily Device Trial The goal of this clinical trial is to test if the Lily Device works to reduce chemotherapy induced hair loss in patients.

2. withpower.com withpower.com/trial/lily-device-for-hair-loss-086d3

Lily Device for Hair Loss (PREVAIL Trial) The RAMACAP helmet-type low-level laser therapy (LLLT) device significantly improved hair density and diameter in patients with androgenetic alopecia after 24 ...

3. cordis.europa.eu cordis.europa.eu/project/id/190130710

LILY: A Breakthrough Technology to Prevent Chemotherapy ... LILY is a portable, comfortable, and effective CIA prevention device that uses localised microvasculature compression therapy (LMCT) to prevent CIA.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408754/

Cancer-Related Alopecia Risk and Treatment - PMC SC was less effective in dose-dense regimens, with only 60% of patients achieving satisfactory hair retention. Most SC failures occurred within ...

5. cnn.com cnn.com/2024/10/18/health/helmet-hair-loss-cancer-treatment-spc

This helmet could help stop hair loss during cancer treatment Their efficiency can vary, but in trials, about half of the patients who tried them retained 50% of their hair or more. But scalp cooling has ...

6. olumiant.lilly.com olumiant.lilly.com/hcp/alopecia-areata/safety

Safety | Alopecia Areata | Olumiant® (baricitinib) - Eli Lilly Find safety information for adult patients with severe Alopecia Areata (AA), including clinical trial data and potential adverse reactions of Olumiant®.