Central Centrifugal Cicatricial AlopeciaNCT04764331
A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
A study testing Revian Red All LED cap in people with Central Centrifugal Cicatricial Alopecia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Central Centrifugal Cicatricial Alopecia
- What is being tested?
- Revian Red All LED cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are eighteen years of age or older with a biopsy-proven diagnosis of CCCA Stage II-III. They also must be on stable treatment without changes (on doxycycline, topical steroids, minoxidil and/or post 8 rounds of intralesional steroids) for at least 3 months.
- Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.
Who cannot join
- Subjects with other forms of hair loss that is not CCCA
- Prior treatment with light source for alopecia
- Males are excluded from this study since the prevalence of CCCA in males is so significantly low that it is difficult to find cases in a clinical setting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest School of Medicine - Dermatology Clinic
Winston-Salem, North Carolina, 27157
Brittany Feaster, 336-407-5731, bfeaster@wakehealth.edu
Irma M Richardon, MHA, 336-716-2903, irichard@wakehealth.edu
About this study
Official title: A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia.
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.
Read the detailed description
The purpose of this pilot study is to determine if the Revian Red All LED cap shows potential to be an effective treatment for CCCA by recruiting hair follicles back to anagen growth or by improving inflammation. 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 disease.
Methods and Measures
Design 5 subjects who are willing to participate in a novel treatment for Revian Red All LED cap will be enrolled in this study. The cap uses two wavelengths of light, 620 nm and 660 nm. A study caps will be provided for each subject. Subjects will use the cap once daily, 10-minute treatment regimen which is the current androgenetic alopecia recommendation. The subjects will use the cap for a total of 6 months.
Standardized photos and dermatoscope photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth.
Prior to study enrollment, all participants will receive a detailed explanation of the purpose of the study and will undergo written informed consent. Clinical history of hair loss and history of prior treatment will be obtained by administering a standardized questionnaire to all subjects. Subjects will also fill out a questionnaire regarding symptoms of their hair loss at each subsequent treatment visit and at follow-up. In order to be eligible, subjects must be diagnosed clinically and histologically with CCCA. Diagnosis will be made only by a board-certified dermatologist.
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Being tested
- Revian Red All LED cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revian Red All LED capDevice
Also called Revian Red
Cap that uses two wavelengths of light, 620 nm and 660 nm will be used once a day for 10 minutes.for treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Caps will be provided for each subjects will use the cap once daily for10-minute treatment regimen Receives: Device: Revian Red All LED cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
hairline stabilization
Pre treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Measured: Change from baseline to month 2
hairline stabilization
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Measured: Change from month 2 to month 4
hairline stabilization
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Measured: Change from month 4 to month 6 (end of study)
hairline regrowth
Pre treatment photographs will be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Measured: Change from baseline to month 2
hairline regrowth
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Measured: Change from month 2 to month 4
hairline regrowth
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Measured: Change from month 4 to month 6 (end of study)
Secondary outcomes (2)
patient assessment of stabilization
Questionnaire will be completed at baseline
Measured: baseline
patient assessment of stabilization
Questionnaire will be completed at end of study
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start6 Jul 2021
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Centrifugal Cicatricial AlopeciaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 5 subjects who are willing to participate in a novel treatment for Revian Red All LED cap will be enrolled in this study. The cap uses two wavelengths of light, 620 nm and 660 nm.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy McMichael, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764331
- Sponsor's protocol ID
- IRB00071484
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia.
- ClinicalTrials.gov ID
- NCT04764331
- Acronym / sponsor ID
- IRB00071484
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this pilot study is to determine if the Revian Red All LED cap shows potential to be an effective treatment for CCCA by recruiting hair follicles back to anagen growth or by improving inflammation. 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 disease.
Methods and Measures
Design 5 subjects who are willing to participate in a novel treatment for Revian Red All LED cap will be enrolled in this study. The cap uses two wavelengths of light, 620 nm and 660 nm. A study caps will be provided for each subject. Subjects will use the cap once daily, 10-minute treatment regimen which is the current androgenetic alopecia recommendation. The subjects will use the cap for a total of 6 months.
Standardized photos and dermatoscope photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth.
Prior to study enrollment, all participants will receive a detailed explanation of the purpose of the study and will undergo written informed consent. Clinical history of hair loss and history of prior treatment will be obtained by administering a standardized questionnaire to all subjects. Subjects will also fill out a questionnaire regarding symptoms of their hair loss at each subsequent treatment visit and at follow-up. In order to be eligible, subjects must be diagnosed clinically and histologically with CCCA. Diagnosis will be made only by a board-certified dermatologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 5 subjects who are willing to participate in a novel treatment for Revian Red All LED cap will be enrolled in this study. The cap uses two wavelengths of light, 620 nm and 660 nm.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: Revian Red All LED capCaps will be provided for each subjects will use the cap once daily for10-minute treatment regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who are eighteen years of age or older with a biopsy-proven diagnosis of CCCA Stage II-III. They also must be on stable treatment without changes (on doxycycline, topical steroids, minoxidil and/or post 8 rounds of intralesional steroids) for at least 3 months.
- Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.
Key exclusion criteria (3 listed)
- Subjects with other forms of hair loss that is not CCCA
- Prior treatment with light source for alopecia
- Males are excluded from this study since the prevalence of CCCA in males is so significantly low that it is difficult to find cases in a clinical setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revian Red All LED capAlso: Revian RedCap that uses two wavelengths of light, 620 nm and 660 nm will be used once a day for 10 minutes.for treatment | Device | Intervention |
Primary outcome
hairline stabilization
Time frame: Change from baseline to month 2
Pre treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline stabilization
Time frame: Change from month 2 to month 4
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline stabilization
Time frame: Change from month 4 to month 6 (end of study)
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline regrowth
Time frame: Change from baseline to month 2
Pre treatment photographs will be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline regrowth
Time frame: Change from month 2 to month 4
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline regrowth
Time frame: Change from month 4 to month 6 (end of study)
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
2 secondary outcomes
patient assessment of stabilization
Time frame: baseline
patient assessment of stabilization
Time frame: month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy McMichael, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revian Red All LED cap in people with Central Centrifugal Cicatricial Alopecia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irma M Richardson, MHA (336-716-2903, irichard@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hairline stabilization (time frame: Change from baseline to month 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.