A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Phase: NA
Conditions: Central Centrifugal Cicatricial Alopecia
Sponsor: Wake Forest University Health Sciences

IRB00094234
NCT05759338
23MAY2024
Revian LED Cap

Study Title: A Pilot Study of Revian Red All LED cap as a novel treatment for Central Centrifugal 
Cicatricial Alopecia.  
Principal Investigator, Co-investigator(s): Amy McMichael, MD, Jorge Larrondo, MD, Ivie Obeime, DO 
Sponsor or funding source: None 
Background, Rationale and Context 
Significance  
Central centrifugal cicatricial alopecia (CCCA) is form of scarring hair loss that predominately affects 
middle-aged women of African descent.1 The etiology remains unknown; however, inflammatory 
mediated destruction of the hair follicles is involved in the pathogenesis. 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 shown to 
be effective in androgenetic alopecia (used once daily, 10-minute treatment regimen) for both men and 
women. Though no head-to-head comparisons have been done, cross-study comparisons suggest it may 
provide greater improvements in hair density than low level red laser devices, topical minoxidil and 
finasteride.6 The cap emits two wavelengths of light, 620nm and 660nm, that lead to the production of 
nitric oxide in the scalp. This increased nitric oxide helps to locally promote blood flow, reduce 
dihydrotestoserone (DHT), and decrease inflammation.6 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.  
Objectives  
The purpose of this 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 
23 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 cap 
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. To use the cap, subjects will connect the Revian Red All LED cap to a 
Smart App on a mobile phone device using Bluetooth. Subjects can use the Smart App to set 
daily reminders to use the cap, track and log usage, and use the 10 minute timer. No additional 
information will be stored on the Smart App. Only subjects will have access to the Smart App 
located on their personal mobile phone device.  
 
Standardized photos and trichoscopic photos before starting treatment and every 2 months for 
x 6 total months will be taken to assess hairline stabilization and potential for regrowth. A 
baseline photo and completion photo will also be taken with a visio device. This will help 
determine pigmentation of the present hairs throughout the study.  
 
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 visit. 
There will be 4 visits total (1 Pre-treatment visit and 3 Follow up visits). In order to be eligible, 
subjects must be diagnosed clinically and histologically with CCCA. Diagnosis will be made only 
by a board-certified dermatologist.  
 
Setting 
This study will be conducted at the Wake Forest Baptist Health Department of Dermatology, 
 
4618 Country Club Road, Winston-Salem, North Carolina 27104.  
 
Subjects selection criteria 
• 
Inclusion Criteria 
o Women who are between the age of eighteen years  and sixty-five years with a 
biopsy-proven diagnosis of CCCA Stage II-IV. 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. 
o Subjects will be recruited from outpatient dermatology clinics at the Wake 
Forest Baptist Health Department of Dermatology. 
• 
Exclusion Criteria 
o Subjects with other forms of hair loss that is not CCCA  
o Prior treatment with light source for alopecia 
o 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 
• 
Sample Size 
We anticipate enrolling 23 subjects in order to assess the effect of Revian Red All LED cap. 

 
Interventions and Interactions 
Each subject will have a clinical assessment of hair loss by the investigator at the start of the enrollment 
and every 2 months until the study is completed. Clinical signs and symptoms of CCCA will be 
documented by administering a standardized questionnaire to all subjects. Subjects will complete the 
standardized questionnaire regarding symptoms of their hair loss at the start of the enrollment and 
every 2 months until the study is completed. Standardized camera and dermatoscopic photographs of 
the scalp will be obtained at the start of the enrollment and every 2 months until the study is 
completed.  
 
 Total Visits (4) 
-Visit 1 (Pre-treatment Visit) 
-Visit 2 (Follow Up Visit, 2 months after Visit 1) 
-Visit 3 (Follow Up Visit, 4 months after Visit 1) 
-Visit 4 (Follow Up Visit, 6 months after Visit 1) 
  
Subjects will use the Revian Red All LED cap, once daily for 10 minutes for a total of 6 months. Subjects 
will also be called every 2 weeks to verbally confirm consistent use of the cap 
 
Outcome Measure(s) 
The main outcome measure in this study is hairline stabilization and/or regrowth, as measured by 
standardized photography, after Revian Red All LED cap treatment. Secondary outcomes include patient 
assessment of stabilization and hair regrowth and reduction of signs and symptoms, if present.  
 
Analytical Plan 
We expect to be able to enroll 23 subjects in this study. Descriptive statistics such as mean, standard 
deviation, and range for demographics and subject characteristics at baseline will be obtained. Severity 
and extent of scalp involvement of CCCA will be assessed by two measures. The first measure will be 
scoring of symptoms obtained from two questionnaires given to subjects (Appendix I and II). One 
questionnaire will be given before treatment begins, and the second questionnaire will be given at the 
start of each subsequent follow up visit (visits 2 and 3) and at the follow-up visit (visit 4). Pre and post-
treatment photographs will also be assessed to determine if further scalp hairline recession is present 
and to look for hair regrowth. The estimates obtained from the subjects’ and physicians’ questionnaires 
(Appendix III) will help in designing a larger, randomized clinical trial.  Given the small number of 
subjects, this study is not powered to test for statistical significance; the study will provide the estimate 
of baseline scores as well as an estimate of change in scores from baseline. 
 
Risk and Benefits 
 
Risks 
Possible risks could include mild discomfort, skin irritation, or temporary erythema at the site of the 
scalp where the cap is applied.  However, most subjects do not experience any side effects  
 
Benefits 
Subjects may or may not receive any direct benefit from their participation. Subjects may have 
improvement of their hair loss, either by regrowth of hair or by cessation/stabilization of hair loss. 
Subjects will be contributing to the general scientific knowledge of potential alternative treatments 
for hair loss with laser therapy, which may be beneficial to the general population in the future.  

 
Human Subjects Protection 
This study does not specifically involve subjects who are particularly vulnerable to coercion or undue 
influence, including pregnant women, prisoners, medical students, and children.  
 
Subject Recruitment Methods 
Subjects will be recruited at the Wake Forest Dermatology clinic. We may also use the Translational Data 
Warehouse or Epic Electronic Health Records in order to identify subjects that may have been seen in 
the Dermatology Clinic before with FFA for upcoming appointments. Subjects who meet the criteria 
mentioned above will be told about the study by either their physician or one of the study investigators. 
They will be asked about their willingness to participate after completion of their regular visit. This 
process will continue until 5 CCCA subjects have been recruited. Study data will be kept secure on a 
password-protected network drive.  
 
Informed Consent 
Signed informed consent will be obtained from each subject by one of the physicians in the Wake Forest 
Dermatology Clinic or by one of the study investigators. Subjects will be recruited from regular clinic 
visits. Consent will be obtained after their regular clinic visit is complete.  
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form.  Any collected 
subject identifying information corresponding to the unique study identifier will be maintained on a 
linkage file, stored separately from the data.  The linkage file will be kept secure, with access limited to 
designated study personnel.  Following data collection subject identifying information will be destroyed 
via shredding 6 years after study closure, consistent with data validation and study design, producing an 
anonymous analytical data set.  Data access will be limited to study staff.  Data and records will be kept 
locked and secured, with any computer data password protected.  No reference to any individual 
participant will appear in reports, presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB and sponsor or appropriate government agency if appropriate. 
 
References 
 
1. Sperling L, Sau P: The follicular degeneration syndrome in black patients: “hot comb 
alopecia” revisited and revised. Arch Dermatol 1992;128:68-74. 
2. Bin Saif GA, Ericson ME, Yosipovitch G. The itchy scalp – scratching for an explanation. Exp 
Dermatol. 2011;20:959–68. 

3. Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been 
achieved, current clues for future research. Dermatol Clin. 2014 Apr;32(2):173-81 
4. Madu P, Kundu RV. Follicular and scarring disorders in skin of  color: presentation and 
management.Am J Clin Dermatol. 2014 Aug;15(4):307-21 
5. Eginli A, Dothard E, Bagayoko CW, Huang K, Daniel A, McMichael AJ. A Retrospective Review 
of Treatment Results for Patients With Central Centrifugal Cicatrical Alopecia. J Drugs 
Dermatol. 2017 Apr 1;16(4):317-320. PMID: 28403264. 
6. REVIAN RED All LED Red Light Therapy For Hair Loss - 10 Minutes Per Day. 2020. Clinical 
Results - REVIAN RED All LED Red Light Therapy For Hair Loss - 10 Minutes Per Day. [online] 
Available at: <https://revian.com/clinical-results/> [Accessed 27 September 2020]. 
 
 
 

Appendix I: Pre-Treatment Questionnaire for subjects  
 
Subject Study Number: ______________(will be 1-5 in the order of enrollment)  
 
1. What is your data of birth? ____________(mm/dd/yyyy) 
 
2. Which one choice best describes your race? (Please choose only one answer) 
____ Black or African American   
If Black or African American is checked, is your ethnic background: 
____ African 
____ Caribbean  
____ Other Black or African descent 
____ Mixed race (Black or African American + Other) 
 
3. What is your ethnicity? (PLEASE CHECK ONLY ONE) 
 
⃞ Hispanic or Latin origin 
⃞ Non-Hispanic or Non-Latin origin 
⃞ Unknown 
 
Hair Loss History  
 
4. When did you first notice your hair loss? _____/______( month/year) 
 
5.  How many dermatologists did you consult for the hair loss on the crown of scalp before a 
diagnosis of central centrifugal cicatricial alopecia (CCCA) was made?   _______________ 
 
6. Have you been given any type of medical treatment for your vertex hairline recession?  
Yes     No   
 
If yes, please check all medications that you used for a time period of AT LEAST 3 MONTHS and 
indicate the effect of each treatment on your hair loss by placing an X in the appropriate box.  
 
Treatment Used 
Response 
Regrowth 
Prevented 
further loss 
Did not stop 
loss 
Do not know 
□ Oral Steroid (e.g. Prednisone) 
  
  
  
  
□ Intralesional (injection into the scalp) steroids 
  
  
  
  
□ Topical steroids (clobetasol, halobetasol, 
fluocinolone, betamethasone diproprionate, 
triamcinolone, fluocinonide, mometasone) 
  
  
  
  
□ Hydroxychloroquine (Plaquenil®) 
  
  
  
  

□ Methotrexate 
  
  
  
  
□ Mycophenolate (Cellcept®) 
  
  
  
  
□ Cyclosporin (Neoral®, Sandimmune®) 
  
  
  
  
□ Topical imiquimod (Aldara®) 
  
  
  
  
□ Spironolactone (Aldactone®) 
  
  
  
  
□ Finasteride (Propecia®, Proscar®) 
  
  
  
  
□ Dutasteride (Avodart®) 
  
  
  
  
□ Tetracycline antibiotic class (e.g. 
Tetracycline®, Doxycycline®, Minocycline® etc.) 
  
  
  
  
□ Topical tacrolimus (Protopic®) 
  
  
  
  
□ Pioglitazone (Actos®) 
  
  
  
  
□ Azathioprine (Imuran®) 
  
  
  
  
□ Topical minoxidil (Rogaine®) 
  
  
  
  
□ Hair transplants in area of hair loss 
□ Other: __________________________ 
  
  
  
  
 
 
 
 
Symptoms  
9. Please indicate your current level of scalp itch from 0-10 by marking the line on the scale 
below 
 
 
 
10. Please indicate your current level of scalp pain from 0-10 by marking the line on the scale 
below 
 
                           
             
 
 
Worst Itch 
Ever 
No 
Itch 
0    1    2    3    4    5    6    7    8    9    10 
Worst Pain 
Ever 
No 
Pain 
0    1    2    3    4    5    6    7    8    9    10 

12. Please indicate your current level of scalp burning from 0-10 by marking the line on the scale 
below.   
                  
       
 
 
13. Please indicate your current level of scalp bumps from 0-10 by marking the line on the scale 
below.  
 
 
14. Would you like to add any other comments? 
______________________________________________________________________________
______________________________________________________________________________
_______________________________________________________________ 
 
Date of Questionnaire completion: ___________________(mm/dd/yyyy) 
 
 
 
Thank you for your time.  
 
Appendix II: Treatment and Follow-Up Questionnaire for Subjects  
 
Subject Study Number: ______________(will be 1-5 in the order of enrollment)  
 
15. Please indicate the effect Revian Red All LED cap treatment had on your hair loss:  
Regrowth     Prevented Further Loss      Did Not Stop Loss     Do Not Know  
 
16.  Please indicate your current level of scalp itch from 0-10  by marking the line on the scale 
below  
             
 
 
Worst  
Burning Ever 
No  
Burning 
0    1    2    3    4    5    6    7    8    9    10 
Worst 
Bumps Ever 
No   
Bumps 
0    1    2    3    4    5    6    7    8    9    10 
Worst Itch 
Ever 
No 
Itch 
0    1    2    3    4    5    6    7    8    9    10 

17.  Please indicate your current level of scalp pain from 0-10 by marking the line on the scale 
below. 
                   
 
 
18. Please indicate your current level of scalp burning from 0-10 by marking the line on the scale 
below.   
     
 
19. Please indicate your current level of scalp bumps from 0-10 by marking the line on the scale 
below.  
 
 
20. Would you like to add any other comments? 
______________________________________________________________________________
______________________________________________________________________________
_______________________________________________________________ 
 
Date of Questionnaire completion: ___________________(mm/dd/yyyy) 
Thank you for your time.  
 
 
 
Appendix III: Clinician evaluation of signs. 
 
SIGNS 
CLINICIAN EVALUATION 
(Mild/Moderate/Severe)* 
Perifollicular scale 
 
Hyperpigmentation 
 
Breakage 
 
Interfollicular scale 
 
Worst Pain 
Ever 
No 
Pain 
0    1    2    3    4    5    6    7    8    9    10 
Worst  
Burning Ever 
No  
Burning 
0    1    2    3    4    5    6    7    8    9    10 
Worst 
 Bumps Ever 
No   
Bumps 
0    1    2    3    4    5    6    7    8    9    10 

Erythema 
 
Loss of follicular openings 
 
Vellus/Intermediate/Terminal hair shaftsa 
 
 
*Mild – affecting <10% of scalp. Moderate – affecting 10-30% of scalp. Severe – affecting >30% of scalp. 
For all signs other than Vellus/Intermediate/Terminal hair shafts (see below).  
a. Percentage of types of hair shafts 
 
Appendix IV: Study Flow Chart 
Perception DLQI 
 
 
 
 
 
DERMATOLOGY LIFE QUALITY INDEX 
 
 
 
 
 
 
 
 
 
 
 
 
 DLQI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Score: 
 
 
 
 
 
 
 
 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER 
THE LAST WEEK.  Please tick  one box for each question. 
 
1. 
Over the last week, how itchy, sore,  
 
 
Very much 
 
 
painful or stinging has your skin   
 
 
A lot 
 
 
 
been?   
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed 
 
 
Very much 
 
 
or self conscious have you been because   
A lot 
 
 
 
of your skin? 
 
  
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
3. 
Over the last week, how much has your   
 
Very much 
 
 
skin interfered with you going 
 
  
 
A lot 
 
 
 
shopping or looking after your home or   
 
A little  
 
 
garden?        
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
4. 
Over the last week, how much has your   
 
Very much 
 
 
skin influenced the clothes  
 
 
 
A lot 
 
 
 
you wear? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
5. 
Over the last week, how much has your   
 
Very much 
 
 
skin affected any social or  
 
 
 
 
A lot 
 
 
 
leisure activities? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  

 
6. 
Over the last week, how much has your   
 
Very much 
 
 
skin made it difficult for   
 
 
 
A lot 
 
 
 
you to do any sport? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
7. 
Over the last week, has your skin prevented 
 
Yes 
 
 
 
you from working or studying?  
 
 
No 
 
 
Not relevant  
 
 
 
If "No", over the last week how much has   
 
A lot 
 
 
 
your skin been a problem at  
 
 
 
A little  
 
 
work or studying? 
 
 
 
 
 
Not at all 
 
 
8. 
Over the last week, how much has your   
 
Very much 
 
 
skin created problems with your   
 
 
A lot 
 
 
 
partner or any of your close friends 
 
 
A little  
 
 
or relatives?  
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
9. 
Over the last week, how much has your   
 
Very much 
 
 
skin caused any sexual   
 
 
 
A lot 
 
 
 
difficulties? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
10. 
Over the last week, how much of a  
 
 
Very much 
 
 
problem has the treatment for your 
 
 
A lot 
 
 
 
skin been, for example by making 
 
 
A little  
 
 
your home messy, or by taking up time?   
 
Not at all 
 
Not relevant  
Please check you have answered EVERY question. Thank you.  
AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the authors. 
 
 
Appendix V: Study Flow Chart 
 
SCHEDULE OF STUDY PROCEDURES 
BASELINE 
VISIT 1 
 
VISIT 2 
 
VISIT 3 
 
VISIT 4 
Post-treatment 
Follow-up 
Informed Consent, HIPPA 
X 
 
 
 
Medical History/Demographic 
information 
X 
 
 
 
Inclusion/Exclusion criteria  
X 
 
 
 
Subject Initial Questionnaire 
X 
 
 
 
Standard Scalp Digital Photography 
X 
X 
X 
X 

DLQI 
X 
 
 
X 
Scalp and hair exam and assessment 
with completion of grader survey 
X 
X 
X 
X 
Dermoscopic photography 
X 
X 
X 
X 
Subject Post-Treatment Questionnaire 
 
X 
X 
X