LED Light Therapy for Alopecia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?Central centrifugal cicatricial alopecia (CCCA) is form of scarring hair loss that predominately affects middle-aged women of African descent.1 . Clinically, the natural progression of CCCA starts at the crown as roughly circular scarred patches, which evolve into scarred areas increasing in size circumferentially. Characteristically, the scar is often smooth and shiny, and the hair density in the affected area is frequently decreased. The hair remaining in the scarred areas is more brittle and shorter than the hair in unaffected areas. Since CCCA is a scarring disorder, it can cause permanent hair loss, dyesthesias, and psychological distress which can affect overall quality of life. Affected individuals may complain of pruritus, pain, or tenderness.2
The management of CCCA is challenging due to limited current treatments and a lack of randomized controlled trails. Management focuses on behavioral and styling modifications, in addition to symptomatic relief. Any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged.3 Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos.4 These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density.5 Since there is limited investigation done to determine the most effective treatment approach for CCCA subjects, it would be of great benefit to determine if there is any advantage in using one particular anti-inflammatory therapy over others and whether one is more efficacious in relieving symptoms or promoting hair regrowth in follicles that have not yet become scarred.
The Revian Red All LED cap is a dual-band LED light therapy wireless "smart" cap. It has been effective in androgenetic alopecia (used once daily, 10-minute treatment regimen) for both men and women. There are also reportedly minimal side effects, unlike with topical minoxidil which can cause pruritus and initial hair shedding in the first few weeks, or finasteride which can cause gynecomastia and loss of libido. In this study we hope to see if the anti-inflammatory capabilities of this cap can improve scalp symptoms, reduce hair loss, and promote maturation of vellus and intermediate hairs in non-scarred areas of the scalp in those affected by CCCA.
How is the Revian Red All LED cap treatment different from other alopecia treatments?
The Revian Red All LED cap is unique because it uses LED light therapy, which is a non-invasive treatment that stimulates hair growth by enhancing blood flow and cellular activity in the scalp. Unlike traditional medications or topical treatments, this method leverages light to potentially improve hair density and health without the need for drugs or chemicals.
23457Is LED light therapy safe for humans?
Studies on LED light therapy for hair growth, including those using red and blue light, have shown no serious adverse effects in both animal and human trials. Some minor side effects, like hair darkening, were observed, but overall, the therapy appears to be generally safe.
34678What data supports the effectiveness of the treatment Revian Red All LED cap for alopecia?
Research shows that red light therapy, similar to the Revian Red All LED cap, can promote hair growth by activating certain pathways in hair follicles. Studies have found that red light can enhance hair growth and improve hair density, making it a promising option for treating hair loss.
12349Will I have to stop taking my current medications?
Participants must be on stable treatment without changes for at least 3 months before joining the trial, so you will not need to stop your current medications if they include doxycycline, topical steroids, minoxidil, or if you have completed 8 rounds of intralesional steroids.
Eligibility Criteria
This trial is for women over 18 with a confirmed diagnosis of CCCA Stage II-III, who have been on a stable treatment plan for at least 3 months. It's not open to men or those with other types of hair loss, nor to individuals who've had prior light therapy for alopecia.Inclusion Criteria
I am a woman over 18 with a confirmed diagnosis of CCCA Stage II-III.
Exclusion Criteria
I am not a male, as males are not eligible for this study.
My hair loss is not due to CCCA.
I have used light therapy for hair loss before.
Participant Groups
The study tests the Revian Red All LED cap, which uses dual-band LED light therapy as a potential treatment for CCCA. The goal is to see if it can reduce scalp symptoms and hair loss while promoting hair regrowth in non-scarred areas.
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Caps will be provided for each subjects will use the cap once daily for10-minute treatment regimen
Revian Red All LED cap is already approved in United States for the following indications:
🇺🇸 Approved in United States as Revian Red for:
- Androgenetic Alopecia
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Wake Forest School of Medicine - Dermatology ClinicWinston-Salem, NC
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
References
Activation of Wnt/β-catenin signaling is involved in hair growth-promoting effect of 655-nm red light and LED in in vitro culture model. [2022]Activation of the Wnt/β-catenin signaling pathway plays an important role in hair follicle morphogenesis and hair growth. Recently, low-level laser therapy (LLLT) was evaluated for stimulating hair growth in numerous clinical studies, in which 655-nm red light was found to be most effective and practical for stimulating hair growth. We evaluated whether 655-nm red light + light-emitting diode (LED) could promote human hair growth by activating Wnt/β-catenin signaling. An in vitro culture of human hair follicles (HFs) was irradiated with different intensities of 655-nm red light + LED, 21 h7 (an inhibitor of β-catenin), or both. Immunofluorescence staining was performed to assess the expression of β-catenin, GSK3β, p-GSK3β, and Lef1 in the Wnt/β-catenin signaling. The 655-nm red light + LED not only enhanced hair shaft elongation, but also reduced catagen transition in human hair follicle organ culture, with the greatest effectiveness observed at 5 min (0.839 J/cm2). Additionally, 655-nm red light + LED enhanced the expression of β-catenin, p-GSK3β, and Lef1, signaling molecules of the Wnt/β-catenin pathway, in the hair matrix. Activation of Wnt/β-catenin signaling is involved in hair growth-promoting effect of 655-nm red light and LED in vitro and therefore may serve as an alternative therapeutic option for alopecia.
Safety of light emitting diode-red light on human skin: Two randomized controlled trials. [2022]Therapeutic applications of light emitting diode-red light (LED-RL) are expanding, yet data on its clinical effects are lacking. Our goal was to evaluate the safety of high fluence LED-RL (≥160 J/cm2 ). In two phase I, single-blind, dose escalation, randomized controlled trials, healthy subjects received LED-RL or mock irradiation to the forearm thrice weekly for 3 weeks at fluences of 160-640 J/cm2 for all skin types (STARS 1, n = 60) and at 480-640 J/cm2 for non-Hispanic Caucasians (STARS 2, n = 55). The primary outcome was the incidence of adverse events (AEs). The maximum tolerated dose was the highest fluence that did not elicit predefined AEs. Dose-limiting AEs, including blistering and prolonged erythema, occurred at 480 J/cm2 in STARS 1 (n = 1) and 640 J/cm2 in STARS 2 (n = 2). AEs of transient erythema and hyperpigmentation were mild. No serious AEs occurred. We determined that LED-RL is safe up to 320 J/cm2 for skin of color and 480 J/cm2 for non-Hispanic Caucasian individuals. LED-RL may exert differential cutaneous effects depending on race and ethnicity, with darker skin being more photosensitive. These findings may guide future studies to evaluate the efficacy of LED-RL for the treatment of various diseases.
Application of superluminescent diodes (sLED) in the treatment of scarring alopecia - A pilot study. [2020]Photobiomodulation therapy with the use of light-emitting diodes (LEDs) is a fast growing therapeutic technique with a wide range of dermatologic indications. Recently it has been suggested that LED therapy could be beneficial in scarring alopecia.
Blue light-emitting diodes in hair regrowth: the first prospective study. [2021]Different studies highlight photo-receptors' presence on the hair follicle that seems to be capable of eliciting hair growth. This study aims to demonstrate blue light's effectiveness on hair growth in patients affected by androgenetic alopecia. Twenty patients enrolled at Magna Graecia University Unit of Dermatology, affected by androgenetic alopecia, were treated with a blue LED light device at 417 ± 10 nm, fluence of 120 J/cm2, and power intensity of 60 mW/cm2 ± 20%. The treatments were performed twice a week for ten consecutive weeks. Patients were evaluated before and 1 month after the end of therapy clinically using standardized global photographs and dermoscopically estimating hair density and hair shaft width. An increase in hair density and hair shaft width was recorded in 90% of patients after 10 weeks. Photographic improvement was noted in 80% of the patients. No serious adverse events have been reported. The only side effect consisted in a darkening of the hair, perhaps due to melanic stimulation due to blue light in 2 patients. Blue light therapy is a promising therapy for patients affected by androgenetic alopecia and other diseases characterized by hair loss. Further studies will be necessary to confirm the findings of this preliminary study.
Phototherapy (cluster multi-diode 630 nm and 940 nm) on the healing of pressure injury: A pilot study. [2023]The therapeutic benefits of LED in wound care have been reported since the 1990s. Nevertheless, studies directly related to the effects of LED phototherapy on the venous and arterial circulation and the healing process of pressure injuries are scarce in literature. Thus, the aim of this study was to evaluate the efficacy of a LED phototherapy prototype in participants with pressure injuries. In this pilot study 15 participants were randomized into three therapeutic groups. The experimental groups received applications of 630 and 940 nm LED three times a week for 8 weeks, with a dose of 6 J/cm2 in Group I. In group II, a dose of 8 J/cm2 in addition to the standard treatment. Group III (control group) received only daily standard treatment which consisted of cleaning the lesioned area with physiological solution, followed by application of an alginate hydrogel dressing over a period of 8 weeks. Pressure injuries were photographed and the area was measured by the Quantikov® image analyzer software. There was no statistically significant difference (p > 0.05) between the three groups when assessing the initial lesion area. At the end of 2 months, the median and interquartile ranges of the injuries were 5.90 (0.79-9.5) cm2 for group I, 0.54 (0.47-1.16) cm2 for group II and 26.76 (17.25-41.05) for group III. There was a statistically significant difference between treatment types (I x III and II x III) for pressure injuries over the 21 sessions. However, there was no significant difference between groups I x II that received different doses of LED phototherapy. The initial hypothesis was supported given that the combination of two wavelengths in the LED phototherapy with different doses may be helpful in accelerating the healing of pressure injuries.
Hair Growth Promoting Effects of 650 nm Red Light Stimulation on Human Hair Follicles and Study of Its Mechanisms via RNA Sequencing Transcriptome Analysis. [2022]Androgenetic alopecia (AGA) leads to thinning of scalp hair and affects 60%~70% of the adult population worldwide. Developing more effective treatments and studying its mechanism are of great significance. Previous clinical studies have revealed that hair growth is stimulated by 650-nm red light.
The efficacy of LED microneedle patch on hair growth in mice. [2023]Light penetration depth in the scalp is a key limitation of low-level light therapy for the treatment of androgenetic alopecia (AGA). A novel light emitting diode (LED) microneedle patch was designed to achieve greater efficacy by enhancing the percutaneous light delivery. The study aimed to investigate the efficacy and safety of this device on hair growth in mice. Thirty-five male C57BL/6 mice which their dorsal skin was split into upper and lower parts to receive either LED irradiation alone or LED irradiation with a microneedle patch. Red (629 nm), green (513 nm), and blue light (465 nm) at an energy dose of 0.2 J/cm2 were applied once daily for 28 days. Outcomes were evaluated weekly using digital photographs. Histopathological findings were assessed using a 6 mm punch biopsy. A significant increase in hair growth was observed in the green light, moderate in the red light, and the lowest in the blue light group. The addition of the microneedle patch to LED irradiation enhanced greater and faster anagen entry in all the groups. Histopathology showed an apparent increase in the number of hair follicles, collagen bundles in the dermis, angiogenesis, and mononuclear cell infiltration after treatment with the green-light LED microneedle patches. No serious adverse effects were observed during the experiment. Our study provides evidence that the newly developed green-light LED microneedle patch caused the optimal telogen-to-anagen transition and could lead to new approaches for AGA. Microneedle stimulation may aid percutaneous light delivery to the target hair follicle stem cells.
Effects of photobiomodulation at various irradiances on normal and dihydrotestosterone-treated human hair dermal papilla cells in vitro. [2023]Androgenetic alopecia (AGA) is the most common type of hair loss caused by dihydrotestosterone (DHT) binding to androgen receptors in dermal papilla cells (DPCs). Photobiomodulation (PBM) is a promising treatment for AGA but suffers from inconsistent outcomes and inconsistent effective light parameters. This study investigated the impact of red light at various irradiances on normal and DHT-treated DPCs. Our results suggested that red light at 8 mW/cm2 was most effective in promoting DPCs growth. Furthermore, a range of irradiances from 2 to 64 mW/cm2 modulated key signaling pathways, including Wnt, FGF, and TGF, in normal and DHT-treated DPCs. Interestingly, 8 mW/cm2 had a greater impact on these pathways in DHT-treated DPCs and altered the Shh pathway, suggesting that the effect of PBM varies with the cellular environment. This study highlights specific factors that influence PBM effectiveness and provides insight into the need for personalized PBM treatment approaches.
Photobiomodulation With a Continuous Wave Red Laser (660 nm) as Monotherapy for Adult Alopecia Areata: A Case Presentation. [2023]Introduction: Alopecia areata (AA) is an autoimmune, inflammatory, non-scarring hair loss in which T-cells target hair follicles. Given that the available therapeutic options generally do not induce and sustain remission of AA effectively and many adverse effects may occur, monochromatic light sources have been recently gaining attention from clinicians. Therefore, the present paper aimed to report the first case in which photobiomodulation therapy (PBMT) with a continuous wave red laser (660 nm) was used as monotherapy for AA. Case Presentation: An isolated round area of complete hair loss was subjected to daily PBMT sessions, resulting in significant regrowth (hair of normal coloration and thickness) within 7 days. On the 21st day, the patient's aesthetic concern was completely resolved. Conclusion: PBMT with a continuous wave red laser seems to be a promising therapeutic option for the treatment of AA; however, additional studies are necessary to obtain more robust evidence.