The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health
Phase: NA
Conditions: Skin Aging, Sun Damaged Skin
Sponsor: Freedom Laser, Inc.

 
 
The Effects of an LED Face Mask & 
Neck and Chest Mask On Skin Health 
 
Protocol Number: 20679 
National Clinical Trial (NCT) Identified Number:  NCT07025837 
Principal Investigator: Swathi Varanasi, PharmD 
Sponsor: Freedom Laser Therapy 
Contract Research Organization: Citruslabs 
Funded By: Freedom Laser Therapy 
Version Number:  v.1.0 
06th September 2024  
 
 
 
 
 
 
Summary of Changes from Previous Version: 
 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
 
STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP), and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR 
Part 812)  
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval.  The protocol and 
consent form must be approved before enrolling any participant.  Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to the 
study.  In addition, all changes to the consent form will be IRB-approved; a determination will be 
made regarding whether a new consent needs to be obtained from participants who provided 
consent, using a previously approved consent form. 
 
 
 

3 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
The Effects of an LED Face Mask & Neck and Chest Mask On Skin Health 
Study Type: 
Single Group, Virtual 
Product(s) being tested 
The iRESTORE Illumina LED Face Mask and The iRESTORE Illumina LED 
Neck & Chest Mask 
Study Intervention 
Description: 
This single-group study will involve 38 participants for a total of 12 weeks.   
 
Participants will use the test products once daily for 10 minutes in the 
evening while getting ready for bed.  
 
Participants will use Mode 1 only for all sessions of the face mask - the neck 
and chest mask does not have multiple settings.  
 
Participants will complete questionnaires at Baseline, Week 2, Week 4, 
Week 6, Week 8, Week 10, and Week 12.  
 
Participants will also provide photos of their faces at Baseline and Week 12 
for dermatologist skin grading.  
 
Participants will utilize the test products at home and complete 
questionnaires online. 
 
Objectives:  
Primary Objective: To examine the effectiveness of the iRESTORE Illumina 
LED Face Mask and The iRESTORE Illumina LED Neck & Chest Mask in 
improving skin health outcomes. 
 
Secondary Objective: To assess changes in participant perception of skin 
health. 
 
Endpoints:  
Primary Endpoint: Improvements in skin health parameters will be evaluated 
by dermatologist grading at Baseline and Week 12. 
 
Secondary Endpoint: Participant perceptions of skin health, including 
plumpness, fine lines and wrinkles, appearance of pigmentation, skin tone 
and texture, skin redness, firmness, and radiance, and the appearance of 
crepey skin will be evaluated through subject-specific questionnaires at 
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12. 
Study population 
38 female participants aged 25-55 
Study Duration: 
12 weeks 
Description of 
Sites/Facilities Enrolling 
Participants: 
Virtual  

4 
Survey Milestones 
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12. 
 
Photo Milestones 
Baseline and Week 12 
Directions For Use: 
Participants will use the iRESTORE Illumina LED Face Mask and The 
iRESTORE Illumina LED Neck & Chest Mask for 10 minutes once daily 
while getting ready for bed.  
 
Participants will use Mode 1 only for all sessions of the face mask. The neck 
and chest masks do not have multiple settings. Full instructions will also be 
written in the manual included with the kit.  
 
iRESTORE Illumina LED Face Mask 
Set Up 
Connect the power cord to the mask. Attach the two parts of the upper strap 
to the mask 
(labeled UL for Upper Left and UR for Upper Right). If desired, attach the 
lower straps as 
well (labeled LL for Lower Left and LR for Lower Right). The lower straps are 
optional and 
are designed to allow the user to pull the mask closer to the face. 
 
Preparation 
Cleanse your face to remove all makeup, skincare, dirt, 
and oils. Place the mask comfortably on your face 
and lightly tighten the straps. Ensure the mask is snug but not too tight. 
Adjust the upper straps upward to relieve pressure. 
 
Step 1 
Press and hold (Power) button to turn on the mask. The mask enters P1 
mode automatically. 
 
Step 2 
Once a mode is selected, press (Start/Pause) button to begin a 10-minute 
session, and 
the indicator light will turn on. Once the session is complete, the indicator 
light will turn 
off, and the mask will turn off automatically in 30 seconds. Note: If the 
(Start/Pause) 
button is not pressed within 30 seconds once a mode is selected, the mask 
will turn off 
automatically. 
 
Step 3 
If you need to pause the session at any time, press the (Start/Pause) button, 
and the 
indicator light will flash. Press the (Start/Pause) button to resume the 
session, and the 
indicator light will turn on. If the (Start/Pause) button is not pressed within 30 
seconds 
during a paused session, the mask will turn off automatically. 
 
Step 4 

5 
Hold the (Power) button for several seconds if you need to turn off the mask. 
The 
indicator light will turn off immediately; then, the mask will turn off in 30 
seconds. 
 
iRESTORE Illumina LED Neck & Chest Mask 
Neck & Chest Mask  
Set Up 
Connect the power cord to the mask. For a full neck and chest treatment, 
attach the 
lower straps (labeled LL for Lower Left and LR for Lower Right) to the two 
ends of the 
mask. If you want to focus on treating the chest only, remove the lower 
straps and attach 
the upper straps (labeled UL for Upper Left and UR for Upper Right) to the 
holes at the top 
of the mask, then let it hang from your neck. 
Preparation 
Position the mask on your chest and around your neck, and lightly tighten 
the strap. Ensure the mask is snug 
but not too tight to cause discomfort. 
 
Step 1 
Press and hold the power button to turn on the mask. 
 
Step 2 
Press the (Start/Pause) button to begin a 10-minute session; the indicator 
light will turn 
on. After the session, the mask will automatically turn off in 30 seconds. 
Note: If you don’t 
press the (Start/Pause) button within 30 seconds, the mask will shut off 
automatically. 
Step 3 
If you want to pause the session at any time, press the (Start/Pause) button, 
and the 
indicator light will flash. Press the (start/pause) button to resume the 
session, and the 
indicator light will turn on. If the (Start/Pause) button is not pressed within 30 
seconds 
during a paused session, the mask will turn off automatically. 
 
Step 4 
Hold the (Power) button for several seconds if you need to turn off the mask. 
The 
indicator light will turn off immediately; then, the mask will turn off in 30 
seconds. 
 
 
Compensation 
$125 Visa gift card 
Devices 
Phone/Digital Camera (participants must provide)  
iRESTORE Illumina LED Face Mask (sponsor provides) 
iRESTORE Illumina LED Neck & Chest Mask (sponsor provides) 
 
 
 

6 
 
 
 
 
 
1.2 
SCHEMA 
 
 
Prior to  
enrollment:  
 
 
 
 
Intervention:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total N=38. Obtain informed consent. Screen potential participants by inclusion and 
exclusion criteria. Participants complete a Baseline questionnaire and take Baseline photos 
of their face, neck, and chest (decolletage area). 
 
Intervention Information 
Study Period = 12 weeks 
Participants will use the face mask and neck and chest masks for 10 minutes daily, while 
getting ready for bed.  
For the face mask, mode 1 should be used for all sessions. The neck and chest mask does 
not have multiple settings. 
Questionnaires will be completed at Baseline, Week 2, Week 4, Week 6, Week 8, Week 
10, and Week 12. 
Photos will be taken at Baseline and Week 12 for expert skin grading. 
 
Final Assessments 
Statistical analysis performed 

7 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
 
Procedures 
Screening 
Intervention 
Conclusion 
Informed Consent 
x 
 
 
Demographics 
x 
 
 
Inclusion/ Exclusion 
x 
 
 
Administer Study 
Intervention 
 
x 
 
Surveys 
x 
x 
x 
Photos 
x 
 
x 
Adverse Event 
Review and 
Evaluation 
x 
x 
x 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
The effects of aging and poor skincare on the face, neck, and chest can be significant, leading to 
various visible changes in skin appearance and texture. As we age, our skin naturally produces 
less collagen and elastin, proteins that provide structural support and elasticity1. This reduction, 
combined with environmental factors like sun exposure and pollution, contributes to the 
development of wrinkles, fine lines, and sagging skin2,3. 
 
The decolletage area, which includes the neck and upper chest, is particularly vulnerable to aging 
signs due to its thin skin and frequent sun exposure4. Common symptoms in this region include 
vertical wrinkles, crepey skin, sun spots, and overall skin discoloration. The face often 
experiences similar issues, along with the formation of age spots, rough patches, and a loss of 
volume that can lead to a sunken appearance5. 
 
Poor skincare habits exacerbate these natural aging processes. Neglecting sun protection, failing 
to moisturize regularly, and not incorporating anti-aging ingredients into one’s routine can 
accelerate skin damage6.  
 
Light therapy devices have emerged as a promising treatment for aging skin. These devices use 
specific wavelengths of light to stimulate collagen production, improve skin texture, and reduce 
the appearance of fine lines and wrinkles7. LED (Light Emitting Diode) therapy, in particular, has 

8 
shown benefits in skin rejuvenation8. Red light therapy can boost collagen production and improve 
skin elasticity, while blue light therapy may help with acne and inflammation9,10. 
 
With this in mind, Freedom Laser Therapy has designed a face mask and neck and chest mask 
that utilize 360 LEDs for the face mask and 230 LEDs for the neck & chest mask to provide firmer, 
smoother, and clearer skin. 
 
2.2 
RISK/BENEFIT ASSESSMENT   
Immediate risks: People taking or using medications that make their skin photosensitive should 
not take part in this study. 
 
Long-term risks: There are no expected long-term risks associated with this product. 
 
Immediate benefits: Participants may experience plumped skin, smoothed fine lines and wrinkles, 
reduced pigmentation, improved skin tone and texture, calmed skin, reduced redness, firmer skin 
and elasticity, improved skin radiance, and reduction of crepey skin on neck and chest. 
 
Long-term benefits: Participants may experience improvements in overall mental health and well-
being due to the immediate benefits of the product. 
 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
TIMEPOINTS 
ASSESSED 
BY 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
Objective: To 
evaluate 
changes in 
overall skin 
appearance, 
as measured 
by 
dermatologist 
skin grading. 
Improvement in 
Skin Appearance 
Baseline and 
Week 12 
Photographs 
via 
Dermatologist 
Skin Grading 
Standardized 
photographs provide 
objective data on the 
changes in skin 
appearance, 
specifically targeting 
wrinkles, fine lines, 
and other signs of 
aging. 

9 
Secondary 
Objectives: 
To assess 
changes in a 
range of skin 
health 
parameters.  
Improvement in 
skin plumpness, 
fine lines and 
wrinkles, 
pigmentation, tone 
and texture, 
redness, firmness, 
elasticity, radiance, 
and appearance of 
crepey skin. 
Baseline, 
Week 2, Week 
4, Week 6, 
Week 8, Week 
12 
Questionnaire
s 
Self-reported 
questionnaires provide 
subjective data on 
perceived changes in 
wrinkles and fine lines.  
 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
This 12-week single-group, virtual clinical study is designed to evaluate the efficacy of the 
iRESTORE Illumina LED Face Mask and The iRESTORE Illumina LED Neck & Chest Mask. The 
study will involve 38 participants, aged between 25 and 55 years, with self-reported skin issues, 
who will use the devices once daily for 10 minutes daily for 12 weeks.  
 
Data collection will include questionnaires at Baseline, Week 2, Week 4, Week 6, Week 8, 
Week 10, and Week 12. In addition, participants will provide photos at Baseline and Week 12 to 
assess changes in skin health and appearance.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
A single-group study is an appropriate design to understand the efficacy and safety of the test 
product. A design that encompasses 12 weeks is also long enough to determine if the supplement 
is effective at improving skin health. The data collection intervals for this trial were chosen to 
minimize the burden on the patients (i.e., not having to travel to a clinic) while still collecting 
valuable data about the efficacy of the test product over time. 
 
 
4.3 
JUSTIFICATION FOR DOSE 
 
The chosen duration and frequency of application are based on established dermatological 
guidelines for similar treatments. This regimen is believed to provide sufficient exposure to light 
therapy to elicit measurable changes in skin condition without overexposure or causing undue 
stress to the skin. The dose is designed to balance efficacy with safety, ensuring that participants 
experience the full benefits of the treatment without significant risk of adverse effects. 
 
 

10 
4.4 
END OF STUDY DEFINITION 
 
The study concludes after 12 weeks, with the final collection of data, photos, and participant 
feedback. Adherence to ethical principles and participant safety is paramount throughout the trial 
process. Should any significant adverse events arise, the study may be adjusted or halted to 
prioritize participant well-being. 
 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
● Female 
● Aged 25-55 years. 
● Willing to follow the study protocols. 
● Self-reported issues with at least two of the following: 
○ Fine lines 
○ Wrinkles 
○ Hyperpigmentation 
○ Dark spots 
○ Reduced elasticity 
● Self-report concerns with at least one of the following: 
○ Crepey skin on the neck and chest  
○ Sun damage on neck and chest 
● Willing to avoid introducing any new products, prescription medications, or supplements 
that target skin health during the study period.  
● If taking oral supplements or herbal remedies targeted at skin health and appearance, 
have been consistently taking these for at least 3 months prior to starting the study.  
● Is willing to maintain the routine of any oral supplements or herbal remedies targeted at 
skin health and appearance for the duration of the study.  
● Has been using the same skincare routine for at least one month prior to the study start 
date.  
● Willing to maintain the same skincare routine and products throughout the study.  
● Willing to avoid direct sun exposure during the study duration 
● Willing to wear sunscreen if have to be in the sun 
 
5.2 
EXCLUSION CRITERIA 
An individual who meets the following criteria will be excluded from participation in this study: 
 
● Anyone who is extremely satisfied with their skin. 
● Anyone who has any chronic health conditions such as oncological (cancer) or psychiatric 
disorders. 
● Anyone who is planning to undergo facial treatments during the study period, including 
botox, dermal filler, chemical peels, etc. or has experienced any of these treatments in the 
last 3 months. 

11 
● Anyone diagnosed with a skin condition affecting the face and/or neck who has had an 
active flare-up or breakout within the last year. This includes but is not limited to acne, 
eczema, psoriasis, rosacea, seborrheic dermatitis, vitiligo, urticaria (hives), warts, atopic 
dermatitis, melasma, and contact dermatitis. 
● Currently using any prescription medications that may affect the skin condition including 
but not limited to the following: 
○ Corticosteroids like prednisone, methylprednisolone  
○ Antipsychotics like olanzapine (Zyprexa), risperidone (Risperdal), quetiapine 
(Seroquel) 
○ SSRIs and SNRIs like fluoxetine (Prozac), sertraline (Zoloft), venlafaxine (Effexor) 
○ Anticonvulsants 
like 
phenytoin 
(Dilantin), 
lamotrigine 
(Lamictal), 
and 
carbamazepine (Tegretol) 
○ Antihypertensives like lisinopril (Zestril), amlodipine (Norvasc), and propranolol 
(Inderal) 
○ Antithyroid 
medications 
like 
Tapazole 
(methimazole), 
Propyl-Thyracil 
(propylthiouracil) 
● Anyone with a history of skin cancer or precancerous skin lesions on the face. 
● Anyone who has any known serious allergic reactions that require the use of an Epi-Pen. 
● Anyone who has any known allergies to ingredients commonly found in skincare products. 
● Anyone who is pregnant, breastfeeding, or trying to conceive 
● Anyone who cannot/will not commit to the study protocol. 
● Anyone with a history of substance abuse.  
● Anyone who has undergone an invasive medical procedure in the three weeks prior to the 
study or has a procedure planned during the study duration.  
● Anyone with a known allergic reaction to aluminum or plastics.  
● Anyone who suffers from any photosensitive disorder (sensitization to light). 
● Anyone with uncontrolled acne.  
● Anyone taking any prescription medication, over-the-counter supplements, or herbal 
supplements  regularly (three or more days per week) that can cause photosensitivity 
including but not limited to the following: 
○ Antibiotics like tetracyclines (e.g., doxycycline, tetracycline) or sulfonamides (e.g., 
Bactrim), fluoroquinolones (e.g., ciprofloxacin, levofloxacin) 
○ Antifungals like Griseofulvin or Vfend (voriconazole) 
○ Diuretics like drugs ending in -thiazides  
○ NSAIDs like ibuprofen and Aleve (naproxen) 
○ Retinoids or Vitamin A (e.g., Accutane (isotretinoin), (Retin-A) tretinoin 
○ Antidepressants (e.g., SSRIs, Elavil (amitriptyline), Tofranil (imipramine) 
○ Antihistamines like Phenergan (promethazine) 
○ Antimalarial medications 
○ Statins like Lipitor (atorvastatin), Zocor (simvastatin) 
○ Antiarrhythmics like Pacerone (amiodarone) 
○ St. John’s wort  
● Anyone who suffers from light-induced headaches or migraines. 
● Anyone with a medical history of seizures or epilepsy triggered by light. 
● Anyone with an electronic implanted device such as a defibrillator, neurostimulator, 
pacemaker, or ECG monitor. 
● Anyone with a known history of carotid artery disease, stroke or transient ischemic attack 
(TIA), carotid stenosis, unstable blood pressure, easy fainting, thyroid disease, or of 
individuals about to undergo surgical procedures in the neck area. 
● Anyone who has stopped hormonal birth control in the past month. 
 

12 
5.3 
PARTICIPANT COMPENSATION 
 
Participants will each receive a $125 Visa gift card. Participants will also be permitted to keep 
the iRESTORE Illumina LED Face Mask and  iRESTORE Illumina LED Neck & Chest Mask. 
 
 
5.4 
JUSTIFICATION OF SAMPLE SIZE 
 
A sample size of 38 participants provides a balance between obtaining statistically significant 
results and maintaining a manageable cohort for detailed analysis and follow-up. 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION  
● Participants will be sent one iRESTORE Illumina LED Face Mask and one iRESTORE 
Illumina LED Neck & Chest Mask. 
● Participants will use both products for 10 minutes daily in the evening. For the face mask, 
Mode 1 should be used for all sessions. The neck and chest mask does not have multiple 
settings. 
● Questionnaires will be completed at Baseline, Week 2, Week 4, Week 6, Week 8, Week 
10, and Week 12. 
● Photos will be taken at Baseline and Week 12. 
 
6.2 
INTERVENTION FORMULATION 
 
N/A 
 
 
 
6.3 
RANDOMIZATION AND BLINDING 
 
There will be no randomization or blinding in this trial.  
 
6.4 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
 
● Pregnancy. 
● Significant study intervention non-compliance. 
● If any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the study would not be in the best 
interest of the participant. 
● Disease progression which requires discontinuation of the study intervention. 
● If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 

13 
● Participants should be withdrawn from study if they start on a new drug or receive 
antibiotics. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on a Case 
Report Form (CRF). Participants who sign the informed consent form but do not receive the study 
intervention may be replaced.  Participants who sign the informed consent form, and receive the 
study intervention, and subsequently withdraw, or are withdrawn or discontinued from the study, 
will not be replaced. 
 
6.5 
PHOTO INSTRUCTIONS 
 
Photographs will be taken at Baseline and Week 12 to document changes in appearance. 
 
Face guidelines: 
● You will be required to provide photos taken straight on, directly facing the camera, and 
from the sides at each measurement time point. 
● Hair should be tied back. 
● The photo should include your full face/head only, with no more than the top of your 
shoulders visible. 
● No cropping: your full face, head, and ears should be included. 
● Please use natural light, in a direction that your phone does not cast a shadow on your 
face when taking the photo, without using the flash. 
● Do not use any type of camera filter setting. No makeup should be worn. Neutral facial 
expression. 
● If possible, take your photos in the same location, at the same time of day, and in the 
same lighting at each check-in. 
 
Neck and Chest Guidelines: 
● The photo should be taken straight ahead. 
● Please use natural light, in a direction that your phone does not cast a shadow on your 
face when taking the photo, without using the flash. 
● Do not use any type of filter setting. No makeup should be worn. Neutral facial 
expression. 
● If possible, take your photos in the same location, at the same time of day, and in the 
same lighting at each check-in. 
 
 
6.6 
REQUIRED DEVICES 
 
Smartphone or digital camera to be provided by participants.  iRESTORE Illumina LED Face 
Mask and The iRESTORE Illumina LED Neck & Chest Mask will be provided by the sponsor.  
 
7 
STATISTICAL CONSIDERATIONS  

14 
Following data collection and the completion of the trial, the data will be analyzed by Citruslabs 
to determine the effect of the intervention. Repeated-measure, between time points, statistical 
tests will be used to examine changes in primary and secondary endpoints versus the Baseline. 
 
 
8 
CONSENT, PRIVACY AND OTHER POLICIES 
 
8.1 
CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given 
to the participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.  The following consent materials are submitted with 
this protocol: informed consent form, photographic consent form, patient bill of rights. 
 
8.2 
CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Consent forms will be 
Institutional Review Board (IRB)-approved and the participant will be asked to read and review 
the document. These documents will explain the research study to the participant and answer any 
questions that may arise. A verbal or written explanation will be provided in terms suited to the 
participant’s comprehension of the purposes, procedures, and potential risks of the study and of 
their rights as research participants.  Participants will have the opportunity to carefully review the 
written consent form and ask questions prior to signing. The participants should have the 
opportunity to discuss the study with their family or surrogates or think about it prior to agreeing 
to participate. The participant will sign the informed consent document prior to any procedures 
being done specifically for the study. Participants must be informed that participation is voluntary 
and that they may withdraw from the study at any time, without prejudice. A copy of the informed 
consent document will be given to the participants for their records. The informed consent process 
will be conducted and documented in the source document (including the date), and the form 
signed, before the participant undergoes any study-specific procedures. The rights and welfare 
of the participants will be protected by emphasizing to them that the quality of their medical care 
will not be adversely affected if they decline to participate in this study. 
 
 
 
8.3 
CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover testing 
of biological samples and genetic tests in addition to the clinical information relating to participants 
(not applicable for this study). Therefore, the study protocol, documentation, data, and all other 
information generated will be held in strict confidence. No information concerning the study or the 
data will be released to any third party without prior written approval of the sponsor.  
 
The study participant’s contact information and records will be securely stored on an AWS server. 
Participant's identities are verified using Stripe Identity, which identifies potential fraudulent users. 
Stripe Identity deletes user data after it is complete and limits access to sensitive data. At the end 
of the study, all records will continue to be kept in a secure location for as long a period as dictated 
by the reviewing IRB, Institutional policies, or sponsor requirements. 
 
 

15 
8.4 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of Citruslabs who is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. 
 
Trial data will be entered into a 21 CFR Part 11-compliant data capture system provided by 
Citruslabs. The data system includes password protection and internal quality checks, such as 
automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. 
Clinical data will be entered directly from the source documents. 
 
8.5 
PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference 
on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, 
or the CRO staff. As a result of deviations, corrective actions are to be developed by the trial 
administrator (Citruslabs) and implemented promptly.  
 
It is the responsibility of Citruslabs to use continuous vigilance to identify and report deviations 
within 7 working days of identification of the protocol deviation, or within 7 working days of the 
scheduled protocol-required activity. Protocol deviations must be sent to the reviewing 
Institutional Review Board (IRB) per their policies. Citruslabs is responsible for knowing and 
adhering to the reviewing IRB requirements. 
 
 
8.6 
PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing 
policies: the study may be published in an open-access preprint server. The study administrators 
(Citruslabs) will be acknowledged in any publications relating to this study. This trial may be 
registered with clinicaltrials.gov and results may be submitted to clinicaltrials.gov following 
publication. No part of this study, including protocol and results, may be published in any form 
without explicit prior approval in writing by the study sponsor. 
 
 
 
8.7 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical.  Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, 
or any aspect of this trial will be disclosed and managed. Furthermore, persons who have a 
perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the design and conduct of this trial.   
 
The sponsor has a conflict of interest, in that they may benefit financially from the success of the 
study. To manage the conflict of interest, an independent third party (Citrusabs) will be handling 
all design and administration of participant-focused materials, all participant recruitment and data 
gathering, and data analysis. 
 

16 
9 
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