Lily Device for Hair Loss
(PREVAIL Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Luminate Medical, Inc.
Must not be taking: Hormone therapy, Anti-estrogen therapy
Disqualifiers: Alopecia, Autoimmune disease, Brain irradiation, others
No Placebo Group
Trial Summary
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)?
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.12345
Is the Lily Device for Hair Loss safe for use in humans?
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.23478
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
See 6 more
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
See 15 more
Trial 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 (Behavioural Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical Research AllianceWestbury, NY
Inspire Health - VinelandVineland, NJ
Inspira Health - Mullica HillsMullica Hill, NJ
Guthrie - Our Lady of Lourdes Memorial HospitalBinghamton, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Luminate Medical, Inc.Lead Sponsor
References
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]Low-level laser/light therapy (LLLT) has been increasingly used for promoting hair growth in androgenetic alopecia (AGA). Our institute developed a new home-use LLLT device, RAMACAP, with optimal penetrating energy, aiming to improve therapeutic efficacy and compliance. To evaluate the efficacy and safety of the new helmet-type LLLT device in the treatment of AGA, a 24-week, prospective, randomized, double-blind, sham device-controlled clinical trial was conducted. Forty subjects with AGA (20 men and 20 women) were randomized to treat with a laser helmet (RAMACAP) or a sham helmet in the home-based setting for 24 weeks. Hair density, hair diameter, and adverse events were evaluated at baseline and at weeks 8, 16, and 24. Global photographic assessment for hair regrowth after 24 weeks of treatment was performed by investigators and subjects. Thirty-six subjects (19 in the laser group and 17 in the sham group) completed the study. At week 24, the laser helmet was significantly superior to the sham device for increasing hair density and hair diameter (p = 0.002 and p = 0.009, respectively) and showed a significantly greater improvement in global photographic assessment by investigators and subjects. Reported side effects included temporary hair shedding and scalp pruritus. In conclusion, the novel helmet-type LLLT device appears to be an effective treatment option for AGA in both male and female patients with minimal adverse effects. However, the limitations of this study are small sample size, no long-term follow-up data, and use of inappropriate sham devices, which do not reflect the true negative control. Trial registration: http://clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=2061 , identifier TCTR20160910003.
Photobiomodulation for the management of hair loss. [2021]Photobiomodulation, otherwise known as low-level laser (or light) therapy, is an emerging modality for the management of hair loss. Several randomized trials have demonstrated that it is safe and potentially effective on its own or in combination with standard therapies. These devices come in many forms including wearable caps or helmets that afford hands-free and discreet use. Models with light-emitting diodes (LEDs) are less expensive compared to laser-based devices and do not require laser safety considerations, thus facilitating ease of home use. Limitations include cost of the unit, risk of information bias, and lack of standardized protocols. Finally, as with any hair loss treatment, patients' expectations with regards to therapeutic outcomes must be managed.
Photobiomodulation and alopecia: a crowdsourced survey study on patient preferences. [2023]Photobiomodulation is a treatment option for hair loss and is currently FDA cleared for androgenetic alopecia. There are a variety of photobiomodulation devices intended for at-home patient use. However, data examining user preferences is lacking. A social media-based, online survey study was completed to understand patient preferences when selecting a photobiomodulation device. Secondary outcomes examined patient experience with the device. Sixty participants responded to the 21-question survey. The majority of participants had never used a photobiomodulation device (n = 50; 86.2%). Most respondents (n = 40; 67.8%) felt the efficacy of the device was the most important aspect to consider when selecting a photobiomodulation device. Additionally, a majority of participants thought 15 (n = 22; 37.3%) or 20 minutes (n = 17; 28.8%) would be a reasonable treatment duration and would prefer a hand-free device (n = 51; 86.4%). Of the eight participants who had used a photobiomodulation device, only one was dissatisfied with the device and discontinued treatment.
Photobiomodulation therapy for androgenetic alopecia: A clinician's guide to home-use devices cleared by the Federal Drug Administration. [2018]The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded, and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. Patients increasingly seek the advice of dermatologists regarding the safety and efficacy of these hair loss treatments. The purpose of this guide was threefold: (1) to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia; (2) to review device design, features and existing clinical evidence; and (3) to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection. A search of the FDA 510(k) Premarket Notification database was conducted using product code "OAP" to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. Thirteen commercially available devices were identified and compared. Devices varied in shape, wavelength, light sources, technical features, price, and level of clinical evidence. To date, there are no head-to-head studies comparing the efficacy of these devices. Photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. However, long-term, high quality studies comparing these devices in diverse populations are lacking. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium.
Quantitative Evaluation of Female Pattern Hair Loss in Chinese Women: A Preliminary Study. [2022]The common grading systems for female pattern hair loss (FPHL), such as Ludwig and Savin scales, are subjective to visual inspection. To provide a more objective evaluation of baldness, the authors have developed a method to calculate baldness quantitatively through a computer-aided imaging system (CAIS).
Home-based devices in dermatology: a systematic review of safety and efficacy. [2022]There is increasing demand for home-based devices for the treatment of dermatologic conditions and cosmesis. Commercially available devices include intense pulsed light, laser diodes, radiofrequency, light-emitting diodes, and ultraviolet B phototherapy. The objective of this report is to evaluate the current evidence regarding the efficacy and safety of home-based devices for the treatment of skin conditions. A systematic search of PubMed, Embase, and Cinahl was conducted on November 9, 2020 using PRISMA guidelines. Original research articles that investigated the efficacy and safety of home-based devices for dermatologic use were included. Bibliographies were screened for additional relevant articles. Strength of evidence was graded using the Oxford Centre for Evidence-Based Medicine guidelines. Clinical recommendations were then made based on the quality of the existing literature. After review, 37 clinical trials were included-19 were randomized controlled trials, 16 were case series, and 2 were non-randomized controlled trials. Ultimately, from our analysis, we recommend the home-based use of intense pulsed light for hair removal, laser diodes for androgenic alopecia, low power radiofrequency for rhytides and wrinkles, and light-emitting diodes for acne vulgaris. Trials investigating ultraviolet B phototherapy for psoriasis revealed mixed evidence for home treatments compared to clinic treatments. All devices had favorable safety profiles with few significant adverse events. Limitations to our review include a limited number of randomized controlled trials as well as a lack of data on the long-term efficacy and safety of each device.
HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. [2021]The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user's hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA).
Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. [2019]Benefit deriving from the use of light is known since ancient time, but, only in the last decades of twentieth century, we witnessed the rapid expansion of knowledge and techniques. Light-emitted diode (LED)-based devices represent the emerging and safest tool for the treatment of many conditions such as skin inflammatory conditions, aging, and disorders linked to hair growth. The present work reviews the current knowledge about LED-based therapeutic approaches in different skin and hair disorders. LED therapy represents the emerging and safest tool for the treatment of many conditions such as skin inflammatory conditions, aging, and disorders linked to hair growth. The use of LED in the treatment of such conditions has now entered common practice among dermatologists. Additional controlled studies are still needed to corroborate the efficacy of such kind of treatment.