5 Participants Needed

LED Light Therapy for Alopecia

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Amy McMichael, MD profile photo
Overseen ByAmy McMichael, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Doxycycline, Topical steroids, Minoxidil
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.26789

Who Is on the Research Team?

Amy McMichael, MD | Wake Forest ...

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.
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention

Revian Red All LED cap is already approved in United States for the following indications:

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Approved in United States as Revian Red for:

Find a Clinic Near You

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.
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.
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.
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]

Citations

Clinical ResultsParticipants 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 ...
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 ...
LED vs. LaserLEDs have greater hair growth, wider light bands, better skin penetration, and more uniform coverage than lasers, making them superior for hair loss treatment.
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 ...
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.
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 ...
LED vs. LaserThis 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 ...
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
LED Therapy in Treating Androgenetic AlopeciaThe 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 ...
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