LED Light Therapy for Alopecia

Overseen By Amy McMichael, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Doxycycline, Topical steroids, Minoxidil

Disqualifiers: Other hair loss, Prior light treatment, Males

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

5 Participants Needed

Trial Summary

Will 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.

What 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. ^{1 2 3 4 5}

Is 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. ^{1 3 6 7 8}

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. ^{1 2 3 7 9}

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.

Research Team

Amy McMichael, MD

Principal Investigator

Wake Forest University Health Sciences

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.

I've been on a stable treatment plan for my condition for at least 3 months.

Participants will be chosen from people who visit the dermatology clinics at Wake Forest Baptist Health Department of Dermatology.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants use the Revian Red All LED cap once daily for a 10-minute treatment regimen

6 months

Monthly visits for standardized photos and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Revian Red All LED cap

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

In a study involving 20 patients with androgenetic alopecia, blue light therapy significantly increased hair density and hair shaft width in 90% of participants after 10 weeks of treatment, indicating its potential efficacy for hair growth.

The therapy was well-tolerated with no serious side effects reported, although 2 patients experienced darkening of their hair, suggesting a safe profile for blue light treatment in hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue light-emitting diodes in hair regrowth: the first prospective study. Lodi, G., Sannino, M., Cannarozzo, G., et al.[2021]

In two phase I clinical trials involving 115 healthy participants, LED-red light (LED-RL) was found to be safe at fluences up to 320 J/cm2 for skin of color and 480 J/cm2 for non-Hispanic Caucasians, with only mild adverse events reported.

The study identified that dose-limiting adverse events, such as blistering, occurred at higher fluences, indicating that LED-RL may have different effects based on skin type, which is important for guiding future therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of light emitting diode-red light on human skin: Two randomized controlled trials. Jagdeo, J., Nguyen, JK., Ho, D., et al.[2022]

In a pilot study involving 16 female patients with scarring alopecia, treatment with superluminescent diodes (sLED) was found to be safe and well tolerated, showing significant reductions in severity scores for both frontal fibrosing alopecia (FFA) and lichen planopilaris (LPP).

The therapy also resulted in a significant increase in the number of thick hairs in the treated area, indicating its potential efficacy as an adjuvant treatment for these conditions, although further research with larger groups is needed to confirm long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of superluminescent diodes (sLED) in the treatment of scarring alopecia - A pilot study. Gerkowicz, A., Bartosińska, J., Wolska-Gawron, K., et al.[2020]

The study found that 655-nm red light combined with LED therapy significantly promotes hair growth by activating the Wnt/β-catenin signaling pathway, as demonstrated in human hair follicle cultures.

This treatment not only enhanced hair shaft elongation but also reduced the transition to the catagen phase, indicating its potential as an effective alternative therapy for alopecia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Han, L., Liu, B., Chen, X., et al.[2022]

Photobiomodulation therapy (PBMT) using a continuous wave red laser (660 nm) showed significant hair regrowth in a patient with alopecia areata within just 7 days of treatment, indicating its potential efficacy as a monotherapy.

By the 21st day of treatment, the patient's hair regrowth was complete, resolving their aesthetic concerns, suggesting that PBMT could be a promising alternative to existing therapies for alopecia areata, though further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation With a Continuous Wave Red Laser (660 nm) as Monotherapy for Adult Alopecia Areata: A Case Presentation. Palma, LF., Campos, L., Álvares, CMA., et al.[2023]

Treatment with 650-nm red light significantly promotes the proliferation of human hair follicles and delays the hair cycle transition from anagen to catagen, suggesting its potential as an effective therapy for androgenetic alopecia (AGA).

RNA-sequencing analysis revealed that 650-nm red light treatment influences various biological processes, including leukocyte transendothelial migration and metabolism, which may play a role in stimulating hair growth and reversing hair miniaturization associated with AGA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair Growth Promoting Effects of 650 nm Red Light Stimulation on Human Hair Follicles and Study of Its Mechanisms via RNA Sequencing Transcriptome Analysis. Yang, K., Tang, Y., Ma, Y., et al.[2022]

The study demonstrated that a novel LED microneedle patch significantly enhances hair growth in mice with androgenetic alopecia, particularly using green light (513 nm), which showed the most effective results compared to red and blue light.

The microneedle patch improved the delivery of light to hair follicles, leading to increased hair follicle count and faster entry into the hair growth phase (anagen), with no serious adverse effects reported during the 28-day treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of LED microneedle patch on hair growth in mice. Kittigul, L., Meephansan, J., Sirithanabadeekul, P., et al.[2023]

Red light at an irradiance of 8 mW/cm2 was found to be the most effective in promoting the growth of dermal papilla cells (DPCs), which are crucial for hair growth, especially in the context of androgenetic alopecia (AGA).

The study revealed that different light irradiances (ranging from 2 to 64 mW/cm2) can modulate important signaling pathways in both normal and DHT-treated DPCs, indicating that the effectiveness of photobiomodulation (PBM) may depend on the specific cellular environment, suggesting a need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of photobiomodulation at various irradiances on normal and dihydrotestosterone-treated human hair dermal papilla cells in vitro. Sun, M., Jiang, H., Lin, S., et al.[2023]

In a pilot study involving 15 participants with pressure injuries, LED phototherapy at 630 and 940 nm significantly reduced the size of wounds compared to standard treatment, with group II (8 J/cm2 LED) showing the most improvement.

Both LED treatment groups (I and II) demonstrated better healing outcomes than the control group, indicating that LED phototherapy can be effective in accelerating the healing process of pressure injuries, although varying doses did not show a significant difference in efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phototherapy (cluster multi-diode 630 nm and 940 nm) on the healing of pressure injury: A pilot study. Baracho, VDS., Chaves, MEA., Huebner, R., et al.[2023]

References

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

Blue light-emitting diodes in hair regrowth: the first prospective study. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Safety of light emitting diode-red light on human skin: Two randomized controlled trials. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Application of superluminescent diodes (sLED) in the treatment of scarring alopecia - A pilot study. [2020]

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

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]

5. Iran pubmed.ncbi.nlm.nih.gov

Photobiomodulation With a Continuous Wave Red Laser (660 nm) as Monotherapy for Adult Alopecia Areata: A Case Presentation. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

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]

7. Germany pubmed.ncbi.nlm.nih.gov

The efficacy of LED microneedle patch on hair growth in mice. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Effects of photobiomodulation at various irradiances on normal and dihydrotestosterone-treated human hair dermal papilla cells in vitro. [2023]

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

Phototherapy (cluster multi-diode 630 nm and 940 nm) on the healing of pressure injury: A pilot study. [2023]