LED Light Therapy for Alopecia

No longer recruiting at 1 trial location

Overseen By Irma M Richardson, MHA

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)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Revian Red All LED Cap, an LED light therapy cap, can help with Central centrifugal cicatricial alopecia (CCCA), a condition causing hair loss and scalp inflammation. The goal is to determine if the cap can stop hair loss and possibly encourage hair regrowth or reduce symptoms. Participants will use the cap for 10 minutes daily over six months. Women with a confirmed diagnosis of CCCA who have been on stable treatment for at least three months may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new solutions for CCCA.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. You must be on a stable treatment without changes for at least 3 months before joining the trial.

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

Research has shown that the Revian Red All LED cap is safe for treating androgenetic alopecia, a common type of hair loss. Studies indicate that this device is non-invasive, meaning it doesn't enter the body, and it can be used hands-free. A previous study tested the cap for Central centrifugal cicatricial alopecia (CCCA) to assess its potential in promoting hair growth and reducing inflammation.

The Revian Red cap uses light therapy, which safely reaches the skin to potentially promote hair growth without causing harm. The FDA has approved the device for treating androgenetic alopecia, indicating its safety.

Overall, the Revian Red All LED cap is generally well-tolerated, with no new safety concerns compared to other similar LED hair treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for alopecia, which often involve medications like minoxidil or finasteride, the Revian Red All LED Cap uses light therapy to stimulate hair growth. This treatment is unique because it employs an all-LED cap that delivers red light therapy directly to the scalp for just 10 minutes a day. The mechanism of action is thought to boost blood circulation and enhance cellular activity, potentially offering a non-invasive and drug-free alternative to current options. Researchers are excited about its potential to provide a convenient and side-effect-free solution for hair loss sufferers.

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

Research has shown that the Revian Red All LED cap, which participants in this trial will use, can effectively stop hair loss and promote new hair growth. In one study, regular use of the cap resulted in an average increase of 26.3 hairs per square centimeter. Another study confirmed that the cap can halt hair loss and encourage regrowth. The cap uses light to lower a hormone called DHT, which is linked to hair loss. This suggests the cap might also help with Central centrifugal cicatricial alopecia (CCCA) by stopping hair loss and possibly aiding in hair regrowth. ^{5 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 aged 18-65 with a biopsy-proven diagnosis of Central centrifugal cicatricial alopecia (CCCA) stages II-IV. Participants must have been on stable treatment, such as doxycycline or minoxidil, without changes for at least 3 months. Men and those with other forms of hair loss are excluded.

Inclusion Criteria

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

I am a woman aged between 18 and 65.

My condition is confirmed as CCCA Stage II-IV through a biopsy.

Exclusion Criteria

My hair loss is not due to CCCA.

I am not a male, as males are not eligible for this study.

I have been treated with light therapy for hair loss.

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 over 6 months

6 months

4 visits (in-person)

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's effectiveness in treating CCCA by promoting hair growth or reducing inflammation. Participants will use the LED cap daily for a 10-minute session to see if it stops hair loss and encourages regrowth.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Using the Revian Red All LED cap 10 minutes each day for 6 months

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. revian.com revian.com/clinical-results/?srsltid=AfmBOoq8q6IUGVUIj2BNhPNEmifftSn8B1izMYeICjYNvbleXDgO-1Fb

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/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 ...

3. revian.com revian.com/revian-in-the-news/top-line-results-show-efficacy-of-led-cap-for-androgenetic-alopecia/?srsltid=AfmBOoryfxRWH_kuzrnHeZHNK_lk4AvYOsir_8oWZO7Q484OSlxh5QX3

Top-line results show efficacy of LED cap for androgenetic ... In the randomized, double-blind, placebo-controlled trial, REVIAN RED demonstrated the ability to stop hair loss and subsequently grow new hair, according to a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12395542/

The Use of Light‐Based Therapies in the Treatment of Alopecia A dual wavelength LED LLLT device (Revian System, Revian Inc.) has been shown to decrease DHT production via stimulated nitric oxide production ...

5. practicaldermatology.com practicaldermatology.com/news/final-data-support-efficacy-of-revian-red-system-for-hair-growth/2460260/

Final Data Support Efficacy of Revian Red System for Hair ... A randomized, double-blind study of the Revian Red hair growth system demonstrated the ability of the system to successfully stop hair loss and subsequently ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K173729.pdf

K173729.pdf - accessdata.fda.gov REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile ...

7. 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05759338

A Study of Revian Red All LED Cap as a Novel Treatment ... The cap is a dual-band LED light therapy wireless "smart" cap. It has been shown to be effective in androgenetic alopecia (used once daily, 10-minute treatment ...

9. revian.com revian.com/research/led-vs-laser/?srsltid=AfmBOopqiz6ecxRuhQ-vNlgNgexAjWAG5Cvx4ggwFhdcXvzrwEb9pTou

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 ...