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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new LED light therapy cap, the Revian Red All LED cap, to address central centrifugal cicatricial alopecia (CCCA), a type of hair loss primarily affecting middle-aged women of African descent. The researchers aim to determine if the cap can reduce scalp symptoms, slow hair loss, and promote hair regrowth in areas not yet scarred. Women diagnosed with CCCA Stage II-III, who have maintained stable treatment for at least three months, may be suitable candidates for this study. Participants will use the cap daily for 10 minutes to evaluate its benefits over existing treatments. As an unphased trial, this study provides an opportunity to explore innovative treatment options for CCCA.

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 prior data suggests that the Revian Red All LED cap is safe for treating alopecia?

Research shows that the Revian Red All LED cap is generally safe for use. This cap effectively treats androgenetic alopecia, a common type of hair loss, in both men and women. Importantly, very few side effects have been reported. Unlike other treatments such as topical minoxidil, which can cause itching and initial hair shedding, or finasteride, which may lead to breast enlargement and reduced sexual desire, the LED cap has not shown these issues.

The device uses LED light therapy, a non-invasive method. The FDA has cleared it for hair regrowth, and it is used once a day for a short, 10-minute session. This approval indicates it meets safety standards for similar conditions. Overall, existing evidence supports that the cap is well-tolerated without introducing new safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for alopecia, which often involve topical medications like minoxidil or oral medications such as finasteride, the Revian Red All LED cap uses light therapy to stimulate hair growth. This LED light therapy works by increasing blood flow and reducing inflammation in the scalp, potentially encouraging hair follicles to enter the growth phase. Researchers are excited about this treatment because it offers a non-invasive, drug-free alternative that requires only a simple, daily 10-minute application, making it convenient and easy to use.

What evidence suggests that the Revian Red All LED cap is effective for CCCA?

Research has shown that the Revian Red All LED cap, used by participants in this trial, can help treat hair loss, particularly in androgenetic alopecia, by increasing hair count. Regular users saw an increase of about 26 hairs per square centimeter. The cap uses LED light, which penetrates the skin more effectively than lasers and covers the area more evenly. This may also aid in treating central centrifugal cicatricial alopecia (CCCA) by reducing swelling and potentially promoting hair regrowth in scar-free areas. Early studies are promising, but further research is needed to confirm its effectiveness for CCCA. ^{2 6 7 8 9}

Who Is on the Research Team?

Amy McMichael, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. revian.com revian.com/clinical-results/?srsltid=AfmBOoqNV5OTOafnqCIc9hWhp4xBfJJYVa04bWpQGIMoKEkWkKOD9Oep

Clinical Results Participants who were treated with the red light therapy and were at least 80% compliant for the duration of the study had an average of 26.3 more hairs per cm² ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05759338

A Study of Revian Red All LED Cap as a Novel Treatment ... The primary outcome is to determine if hair loss regression is halted. Secondary outcomes include hair regrowth and alleviation of signs and symptoms of the ...

3. revian.com revian.com/research/led-vs-laser/?srsltid=AfmBOopbRlqvdeZbumHa2aDPc6TOv6Bv7VIJYvYd7lettPeiAhdHs_mB

LED vs. Laser LEDs have greater hair growth, wider light bands, better skin penetration, and more uniform coverage than lasers, making them superior for hair loss treatment.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04764331?cond=Central%20centrifugal%20cicatricial%20alopecia%20OR%20%22%22&aggFilters=status:not%20rec&viewType=Table&rank=3

A Pilot Study of Revian Red All LED Cap as a Novel ... The primary outcome is to determine if hair loss regression is halted. Secondary outcomes include hair regrowth and alleviation of signs and symptoms of the ...

5. dermatologytimes.com dermatologytimes.com/view/revian-reports-promising-results-in-initial-study-for-hair-regrowth-system

Revian Reports Promising Results in Initial Study for Hair ... Revian Inc. has reported 1 promising initial study results for its Revian RED Hair Growth System, indicating that a second study of the device is in the works.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K242441.pdf

September 13, 2024 Revian, Inc. Tammy Carrea VP Quality ... Thus, the Revian Lyte device does not introduce any new issues of safety or effectiveness compared to Revian Red or other similar LED hair ...

7. revian.com revian.com/research/led-vs-laser/?srsltid=AfmBOorMn8FG3laQOib1Rt2Bgc5LYSNj34XeDpYGuwpSNOcqhkEvyrAi

LED vs. Laser This study10 shows light emitted by LEDs used in the Revian RED cap penetrate 4-5 mm thick human skin samples at a transmission range of 17.1 – 18.4%, while the ...

8. amazon.com amazon.com/Wireless-Smartphone-Treatment-Thinning-Regrowth/dp/B07Q5ZNKSN

REVIAN Red Cap Hair Growth Device LED Wireless FDA ... LED Wireless FDA Cleared Red Light Therapy for Hair Regrowth, Hair Loss Treatment for Men + Women, Thinning, Regrowth & Alopecia with Smartphone App

9. revian.com revian.com/wp-content/uploads/2024/04/Revian-LED-vs-Laser-Therapy_1500-000061-r01.pdf?srsltid=AfmBOoqNAQispKaJwHRykeaFY2oCwgICBEK4bynxjVPt69D5PwgGQrSh

LED Therapy in Treating Androgenetic Alopecia The purpose of this paper is to assist hair-loss treatment professionals in choosing the best light therapy option for their patients. FDA-cleared devices using ...