Clinical trial NCT03830177
Conditions: Dermatitis, Seborrheic Dry Skin; Eczema
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Start date: 2019-07-08; Completion date: 2023-10-04
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of a novel topical treatment for dry scalp conditions, including dandruff, seborrheic dermatitis, and atopic dermatitis. The study investigates clinical improvements in symptom severity, participant experience with the treatment, and changes in the scalp microbiome before and after use. By studying this treatment, the investigators aim to provide children and adults with a natural, effective option for managing dry scalp conditions.

Detailed description:
This study evaluates the safety and efficacy of a novel topical scalp treatment for dry scalp conditions, including dandruff, seborrheic dermatitis, and atopic dermatitis. The treatment contains Lactobacillus sp., honey, and turmeric in an emollient base, hypothesized to alleviate symptoms by addressing microbial imbalances, reducing inflammation, and promoting scalp hydration.

The study will enroll 15-40 pediatric participants aged 1-17 years and 20-40 adults aged 18 and older, all clinically diagnosed with dry scalp. All participants will apply the treatment over a 14-day period. Adults will use the treatment daily, while pediatric participants will apply it 2-3 times weekly. Other scalp therapies will be discontinued during the study period.

The study aims to explore the treatment's potential to improve clinical severity, enhance quality of life, and positively impact the scalp microbiome, providing a natural, effective option for managing dry scalp conditions.

Arms: arm 1: All participants receive a topical scalp treatment containing Lactobacillus sp., honey, and turmeric. Adults apply the treatment daily for 14 days, while children apply it 2-3 times weekly for 14 days.
Interventions: intervention 1: Natural Treatment
Intervention descriptions: intervention 1: Participants will receive a topical treatment formulated with natural ingredients (Lactobacillus sp., honey, and turmeric) and a kit containing all necessary materials, including an instruction handout. The treatment is applied to the scalp, left for roughly 5 minutes, and rinsed off.

Protocol documents:
Prot_SAP_000.pdf: 
Protocol 
 
Title: 
Safety and efficacy of a topical scalp treatment for dry scalp conditions in 
children and adults 
 
 
Principal Investigator 
Lucy Bilaver, PhD 
Northwestern University 
750 N Lake Shore Drive, Suite 680 
Chicago, Illinois 60611 
 
Email: l-bilaver@northwestern.edu 
 
 
Co-Investigators 
Peter Lio, MD 
Northwestern University 
Medical Dermatology Associates of Chicago 
363 W Erie Street, Suite 350 
Chicago, IL 60654 
 
p-lio@northwestern.edu 
 
 
 
Statistician 
Christopher Warren, PhD 
 
Version Date: 
March 10th, 2023 


1 
 
 
STUDY TITLE 
Table of Contents 
1. BACKGROUND AND RATIONALE 
2. STUDY DESIGN 
3. STUDY OBJECTIVES 
4. STUDY POPULATION 
4.1. Inclusion criteria 
4.2. Exclusion criteria 
5. STUDY PROCEDURES 
6. DATA COLLECTION AND REPORTING 
6.1. Primary Outcome Measures 
6.2. Secondary Outcome Measures 
7. DATA DISCLOSURE AND SUBJECT CONFIDENTIALITY 
8. EFFICACY ASSESSMENT 
9. SAFETY ASSESSMENT 
10. STATISTICAL CONSIDERATIONS 
11. POTENTIAL PITFALLS 
12. STUDY SITE 
13. ETHICAL CONSIDERATIONS 
13.1. Human Subjects Protection 
13.2. Consent Forms 
13.3. Protocol Amendments 
13.4. Retention of Records 
13.5. Use of Information and Publication 
14. APPENDIX 
15. REFERENCES 


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STUDY TITLE 
  Safety and efficacy of a topical scalp treatment for dry scalp conditions in children and adults 
1. BACKGROUND AND RATIONALE: 
Dry scalp conditions (dandruff, seborrheic dermatitis, atopic dermatitis) impacts half of the human 
population and is characterized by dry scalp and fine, loosely adherent, white flakes (Borda 2015). 
Patients report pruritus, irritation, and a tight-feeling scalp. Dry scalp may be caused by an imbalance 
of bacteria, colonization of fungi, or abnormal sebum production. Current treatment is limited in 
efficacy and involves moisturizing or prescription creams or shampoos, along with avoiding triggers or 
behaviors that exacerbate the condition. A study in 2003 reported the prevalence of seborrheic 
dermatitis in children and found that seborrheic dermatitis is very prevalent in children younger than 5 
months. Of the children in the study, nearly 72% of children younger than 3 months old had seborrheic 
dermatitis and 50% of children ages 3-5 months had seborrheic dermatitis (Foley 2003). 
 
Recent studies have highlighted the potential role of changes in the skin bacterial and fungal 
community—the skin microbiome—in exacerbating inflammation of atopic skin. The changes show 
differing dominating bacterial and fungal strains in healthy and diseased skin (Park 2017). Lesional skin 
has been shown to be dominated by Staphylococcus bacteria and contain a lower microbial diversity than 
adjacent non-lesional skin (Kong 2012, Seite 2014). It is hypothesized that Staphylococcus aureus plays a 
critical role in the pathogenesis of eczema: the density of S. aureus in eczema patients can be staggering 
at 107 colonies per square centimeter of atopic skin, representing a far greater burden than those observed 
in other forms of skin inflammation (Lin 2007, Cho 2001). Staphylococcus is also a major bacteria found 
on atopic scalps (Park 2017). Though the precise link between dysbiosis, eczema, and dry scalp in 
humans remains unclear, these results warrant further investigation into the role of antimicrobial therapy 
in reversing dysbiosis and its’ potential exacerbation of disease severity. 
 
The use of hydrating emollients is effective on atopic skin, in which dry cracks allow irritants to pass and 
exacerbate the condition (Hanifin et al 2004). Emollients have been found to change skin communities 
from a disease to healthy state (Seite 2014). Of especial relevance, a 2014 study showed that topically 
allied emollients containing Lactobacillus sakei were effective in a split body trial at reducing common 
symptoms of eczema (Park 2014). As topical therapy, honey has been shown to work synergistically 
with antibiotics to treat methicillin-resistant S. aureus (Liban 2013). Honey possesses the antibacterial 
potency needed to stop the growth of S. aureus. and histologic studies show early decreases in 
inflammation, better infection control, and faster healing times (Lusby 2002). In addition, curcumin, the 


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active ingredient in turmeric, has also shown to be beneficial in skin disease. Although research on 
curcumin is not extensive, it has demonstrated antioxidant and anti-inflammatory properties in preclinical 
trials. Its lack of toxicity, even at high doses, makes it an attractive, natural treatment option 
(Thangapazham et al 2007). 
 
We aim to characterize the safety and efficacy of a topical preparation of Lactobacillus sp., honey, and 
turmeric in an emollient base in restoring the scalps of those with dry scalp to more closely resemble the 
healthy scalps.  
 
2. STUDY DESIGN AND SYNOPSIS: 
This pilot study consists of participants diagnosed with dry scalp. Participants will receive the required 
topical vehicle with the treatment condition (containing dead bacteria) on their scalp.  This study will 
consist of 15-40 participants’ ages 1 years old to 17 years old and 20-40 participants 18 and older with a 
clinical diagnosis of dry scalp. Participants will be recruited either while visiting a dermatologist for a 
standard office visit, while visiting a pediatrician for a standard office visit, or by coming into Children’s 
Healthcare Associates, Medical Dermatology, or our Northwestern research office to be assessed by a 
physician. Each study visit will take approximately 15-20 minutes. 
 
No randomization will occur, as all participants will receive the active treatment. Each adult participant  
will apply the active treatment once daily for a study period of 14 days and discontinue using all other 
scalp management therapies. Each child participant (with the help of a caregiver, if needed) will apply 
the active treatment once every 2 to 3 days for a study period of 14 days and discontinue using all other 
scalp management therapies. 
 
The primary goal of this study is to determine the safety and effectiveness of Lactobacillus sp., honey, and 
turmeric in reducing dry scalp symptomology. 
 
 There are three goals in the comparison of these conditions:  
• The first is to find the effectiveness of the active treatment in improving clinical disease severity. 
To accomplish this, an investigator will assess the severity of dry scalp before and after the 
treatment period using the 11-point flaking scale (Neumann 1996), respectively.  
• The second goal is to determine whether the active treatment is safe. This will be accomplished by 
contacting the patient via over the phone and through daily emails designed to document adverse 
events and Overall Safety Score. The Overall Safety Score is a 4-point assessment ranging from 
“no signs of irritation” (0) to “patient discontinued due to irritation” (3). Participants will be asked 
about the Overall Safety score at the halfway point and the end point of the study.  
• The third exploratory goal is to determine whether the microbiome can be changed.   This will be 


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accomplished by obtaining swab samples from the participants’ scalps, before and after the 
treatment period. The samples will be analyzed using 16s RNA sequencing and internal transcribed 
spacer (ITS) sequencing. Additionally, the change in colony count of bacterial and fungal colonies 
on the scalp before and after the treatment will be assessed using the Replicate Organism Detection 
and Counting (RODAC) method. We aim to characterize the effects of Lactobacillus sp., honey, 
and turmeric on dry scalps.  
• Finally, this study will determine the quality of life of participants before and after the treatment 
period. Quality of life will be calculated using the ScalpDex tool, a validated 23-item instrument 
that explains the way that patients with scalp dermatitis are affected by symptoms, functioning, 
and emotions.  
 
3. STUDY OBJECTIVES: 
The first goal of this study is to determine the effectiveness of introducing Lactobacillus sp., honey, and 
turmeric, in reducing dry scalp symptomology. 
 
Hypothesis 1a: Participants’ scalps treated with vehicle plus Lactobacillus sp., honey, and  
turmeric preparation will exhibit decreased dry scalp severity on assessment by an 
investigator when compared to the scalps before treatment, as measured by an 11-point 
flaking scale. 
 
The next objective is to determine the safety of introducing Lactobacillus sp., honey, and turmeric, in 
reducing dry scalp symptomology 
 
 
Hypothesis 2a: The product containing Lactobacillus sp., honey, and turmeric will be safe for 
participant’s scalps as measured by the Overall Safety Score and patient logs.  
 
The final objective of this study is to compare the determine if an active Lactobacillus, honey, and 
turmeric topical preparation changes the microbiome after use for a dry scalp condition to more closely 
resemble healthy scalp 
 
Hypothesis 3a: Participants’ scalps treated with the active Lactobacillus, honey, and turmeric 
preparation will have a microbiome similar to those with healthy scalps. 
 
4. STUDY POPULATION: 
We aim to recruit participants with diagnosed dry scalp and with clinical signs on the scalp. Recruitment 
will consist of male and female participants. This will include 15-40 children between the ages of 1 year to 
17 years old, and 20-40 adults over the age of 18. 


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4.1.1. 
Inclusion criteria 
a. Age 1 year (or corrected age of 1 year, for those born prematurely) to 17 years for children, and 
adults 18 and older 
b. Patients with dry scalp and dandruff symptoms as determined by a board-certified 
Dermatologist, Allergist, or Pediatrician  
c. Good general health  
d. Participant and/or their parents are able to read, write, and understand study materials in English 


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4.1.2. 
Exclusion criteria 
e. Infants younger than 1 year old  
f. Patients diagnosed with other scalp diseases such as psoriasis, tinea capitis, and pediculosis 
capitis 
g. Systemic steroid or oral antibiotic use during the past two months  
h. Allergy to any of the preparation components 
 
 
5. STUDY PROCEDURES: 
For this study, 20-40 subjects over the age of 18 and 15-40 subjects aged 1 year to 17 years, all with a 
clinical diagnosis of dry scalp, will be enrolled. 5-10 adults participants will be enrolled and complete 
the study prior to enrolling children. All participants who fit the inclusion criteria and are currently 
being seen at either a Lurie Children’s location, Children’s Health Associates, the Medical 
Dermatology Associates of Chicago, or other outside locations, will be verbally invited to participate in 
the study, immediately following their regularly scheduled appointment, by a study coordinator will be 
administered informed consent. Additionally, those not able to attend a standard office visit, will come 
into our Northwestern office to be assessed by a board-certified physician. Study staff will identify 
potentially eligible study patients from clinic databases or those who have previously shown interest 
and mail or email these patients a letter with information on the study protocol, eligibility criteria and 
participant compensation, as well as instructions to contact study staff if interested in participation. We 
will also wait a week after mailing the potentially eligible study patients and call and/or e-mail them to 
see if they are interested in participation. 
A research coordinator will obtain bilateral culture swabs of the scalp, in order to assess the 
composition of the local bacterial community. A research coordinator will also obtain bilateral cultures 
of each participant’s scalp via the RODAC plate method in order to assess the burden of S. aureus on 
the skin. Swab and culture samples will be sent to the lab of Dr. Patrick Seed at Lurie Children’s or to 
Dr. Mahboobeh Mahdavinia’s lab at Rush University to be processed via 16s rRNA sequencing and 
colony count, respectively. Lastly, a board-certified physician will assess the clinical severity of the 
participant’s dry scalp via the 11-point flaking scale. Photographs will be taken as record for both adult 
and child studies.  
 
Each participant will then fill out a baseline survey including demographics in REDCap.  
 


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Participants will be supplied with the scalp treatment and relevant instructions. Participants will be 
instructed to apply the preparation to their scalp. Adults will apply the scalp treatment on the site of active 
dry scalp once per day at home at a consistent time, every day for 14 days. Children will apply the hair 
care regiment at home at a consistent time two to three times a week over a 14-day period. -. Participants 
will be instructed to discontinue their regular scalp-care therapies. Adult participants will be contacted 
daily via email or telephone regarding scalp care regimen, usage of treatment, and any adverse events. 
Child participants will be contacted weekly via email or text regarding scalp care regiment, usage of 
treatment, and any adverse events. One week from the baseline visit (7 days), the participant will be 
contacted via phone, text or email to complete surveys regarding treatment experience and to confirm 
correct usage of treatment. Fourteen days following the baseline visit, adult participants will be seen, 
where repeat scalp cultures will be obtained via the swab and RODAC methods, and a repeat scalp flaking 
survey (IGA) (with photographs) will be assessed by a physician.  Final experience surveys will be 
administered via REDCap. Fourteen days following the baseline visit, child participants will attend a 
secondary visit, where a physician will assess the participants' scalp and re-evaluate the IGA placement. 


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Study Schema 
 
VISIT 1: (baseline)  
- Recruitment and electronic informed consent of participants via REDCap.  
- Obtain baseline scalp culture skin swabs from participant for microbiome diversity analysis. 
- Obtain baseline scalp cultures from participant via RODAC method to obtain initial bacterial burden level. 
The RODAC (Replicate Organism Detection and Counting) method is used to measure the number of 
colony forming units (CFU) per skin surface area. The primary purpose of the RODAC method is to monitor 
presence and number of microorganisms as determined by the appearance of colonies on the surface of an 
agar medium.  
- Local scalp flaking survey performed to the participant by investigator. Photographs will be taken. - 
Administer baseline demographics survey via REDCap.  
- Demonstrate/teach patients the treatment regimen. The treatment for adults will be applied daily for 14 
days for 5 minutes. The treatment for children will be applied 2 to 3 times a week over the course of 14 
days for 5 minutes. 
- Instruct adult participants to respond to the daily scalp care emails or phone calls. Instruct child 
participants to weekly scalp care emails, text messages, or phone calls.- Provide participants with all study 
materials, including instruction handout.  
-Instructions for adults will be given stating: Wash your hands and make sure scalp/hair is dry, and then 
apply the treatment to your entire scalp. Massage the treatment in, wait around seven minutes, and then 
rinse it from your scalp. Please be sure to apply the treatment daily. Instructions for children will be given 
stating: Wash your hands and make sure scalp/hair is dry, and then apply the treatment to your entire scalp. 
Massage the treatment in, wait  approximately five minutes, and then rinse it from your scalp. Please be 
sure to apply the treatment 2 to 3 times a week.  
FOLLOW-UP:  
- Study coordinator will contact participant or caregiver via phone or email daily to ensure safety of 
treatment regimen. Dr. Bilaver will follow-up with patients if adverse events are reported.  
-Quality of life and overall safety score surveys will be sent to participants at the 7 day mark. 
VISIT 2 at Lurie Children's, Northwestern University, or Medical Dermatology Associates of 
Chicago: (14 days after baseline)  
- Obtain scalp culture skin swabs from patient for microbiome diversity analysis.  
- Obtain scalp cultures from patient via RODAC method to obtain final bacterial burden level.  


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- Local scalp flaking survey performed to patient by investigator. Additional photographs will be taken. 
- Ask participants to fill out the follow-up questionnaire via REDCap during the visit on a study iPad. 
 
 
 
Events performed outside of patient visits:  
-Skin swabs and RODAC plates will be transported from the collection site to the laboratory of Dr. Patrick 
Seed or to Dr. Mahboobeh Mahdavinia’s lab at Rush University. The team will use an insulated carrier to 
transport the samples directly following each visit. 
 
 
 
 
For visit 1 and 2, the study visit will take place at either Lurie Children's, Northwestern University, 
Children’s Healthcare Associates, or Medical Dermatology Associates of Chicago. A board certified 
Dermatologist, Allergist, or Physician/pediatrician will conduct a scalp assessment to determine whether 
the participant is eligible for the study. Dr. Lucy Bilaver, the PI, will be the primary contact in the event of 
an adverse event, but will not be involved directly with any items in visit 1, the follow up, or visit 2. A 
research coordinator will consent the participant, explain the procedures of the study, swab the scalp, and 
administer the surveys. Either a research coordinator or physician will take pictures of the patient's scalp. 
The same responsibilities for the physician and research coordinator will take place at visit 2. For the adult 
follow ups, a research coordinator will either email or call the participant daily (based off their preference) 
regarding treatment use and adverse effects. Storage will occur at Dr. Patrick Seed's Lab (Lurie 
Children's) and Dr. Mahboobeh Mahdavinia’s lab at Rush University, and analysis will be done by Dr. 
Seed’s lab and Dr. Mahdavinia’s lab at Rush University. 
 
Parents will be asked to perform the treatment on children ages 1-11, but children ages 12 years-17 years 
will be asked to perform the treatment themselves. Parents will complete surveys for all children 
regardless of age. 
-  
 
6. DATA COLLECTION AND REPORTING: 
 
 
At baseline, culture swabs will be obtained from all patients’ scalp via both the swab and RODAC 
method. Patients will fill out an intake survey including demographics via REDCap. The physician will 
complete a scalp flaking survey to evaluate initial disease severity. 
 
At the 7-day mark, adult patients will be emailed or texted surveys to ensure the treatment regimen and 
daily instructions are being completed correctly as well as to assess the safety and efficacy of the 
treatment.  At the 7-day mark, child patients will be emailed or texted surveys to ensure the treatment 
regimen and weekly instructions are being completed correctly as well as to assess the safety and 


10 
 
efficacy of the treatment. All questions will be answered and noted on a secure Northwestern server. 
 
At the 14-day follow-up visit, cultures will again be obtained from the patients’ scalp via the swab and 
RODAC methods. The investigator will complete the scalp flaking survey to evaluate endpoint disease 
severity. Patients will then fill out a follow-up questionnaire via REDCap. 
At the 14-day follow-up visit for child participants, the investigator will complete the scalp flaking 
survey to evaluate endpoint disease severity. Patients will then fill out a follow-up questionnaire via 
REDCap. 
 
Participants will only be identified via their coded numeric subject ID. The document linking the code to 
the participant will be stored on a secure Northwestern server and all study team members will have 
access to the server. 
 
Informed consent and all surveys will be programmed into REDCap NUBIC by a member of the study 
team. All other data will be stored in an electronic database and stored on a secure Northwestern server. 
Only those outlined in the IRB will have access to the information. 


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6.1. Primary Outcome Measures 
The primary objective is to determine the safety and efficacy of YoBee in improving dry scalp 
conditions. Efficacy will be determined using the Investigator’s Global Assessment (IGA) scale (Table 
1), a 5-point assessment ranging from clear (0) to severe disease (4) and the Total Severity Scale (TSS) 
(Table 2), an assessment that averages erythema, scaling, and pruritus severity scores of scalp lesions. 
The TSS uses a 4-point scale ranging from none (0) to severe (3). Lastly, photographs of the scalp will 
be collected before and after treatment. Safety will be determined by contacting the patient via over the 
phone  or through email to document adverse events and Overall Safety Score. The Overall Safety 
Score (Table 4) and the reporting of adverse events throughout the study will measure the safety of 
YoBee. The Overall Safety Score is a 4-point assessment ranging from “no signs of irritation” (0) to 
“patient discontinued due to irritation” (3). Participants will include the Overall Safety Score 
assessment in their daily journal.  
An exploratory aim of this study is to find whether YoBee changes the microbiome after use for a dry 
scalp condition to more closely resemble healthy scalps. This will be accomplished by obtaining swab 
samples from the participants’ scalps, before and after the treatment period. The samples will be 
analyzed using 16s RNA sequencing and internal transcribed spacer (ITS) sequencing. Additionally, 
the change in colony count of bacterial and fungal colonies on the scalp before and after the treatment 
will be assessed using the Replicate Organism Detection and Counting (RODAC) method. Finally, 
ScalpDex, a validated instrument, will assess the change in quality of life of participants. ScalpDex is a 
23 question survey that will be administered electronically via RedCap to participants. 
7. DATA DISCLOSURE AND SUBJECT CONFIDENTIALITY: 
Subject medical information obtained as a result of this study is considered confidential, and disclosure to 
third parties other than the principal investigator and the co-investigators is prohibited. Data may only be 
disclosed in relation to compliance with mandatory state and federal disclosure laws, and will not be 
disclosed in any other circumstance. All reports and communications relating to subjects in this study  
will identify each subject only by their initials and study identification number. Medical information 
resulting from the subject’s participation in this study may be given to the subject’s personal physician or 
the appropriate medical personnel responsible for the subject’s welfare. Data gathered as a result of this 
study are available to inspection on request by the Lurie Children’s Hospital Institutional Review Board 
(LCHIRB). 
 
8. EFFICACY ASSESSMENT 


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The efficacy of our trial will be measured by an 11-point scalp flaking scale (IGA). Second, we will employ 
16S rRNA gene sequencing to analyze the composition of the scalp microbiome before and after treatment. 
Finally, efficacy toward reducing Staph colonization will be quantified via colony count of S. aureus scalp 


13 
 
cultures  from  patients  plated  on  RODAC  plates,  and  compared  against  each  patient’s  baseline 
measurements. 
 
9. SAFETY ASSESSMENT 
All of the ingredients contained in our topical formulation are either foods or commonly used in 
cosmetics and skin care products. As such, we have minimal reason to believe that participants will 
experience major adverse events from treatment. There may be a risk of mild irritation, given the nature 
of already inflamed skin, but this should be minimal as compared to current accepted topical treatments 
for dry scalp. This study utilizes dead Lactobacillus species to eliminate the risk of growth and thus, 
the risk of new disease or symptomatology. Furthermore, dead bacteria are easier to store and offer a 
longer shelf life, eliminating the risk of application of an unknown size or species of bacteria.  
 
10. STATISTICAL ANALYSIS 
Responses for the scalp flaking survey are measured on an 11-point scale. The identification and relative 
quantities of scalp bacteria will be measured via 16S-tag count and expressed as a percentage of the total 
number of 16S-tags per sample, while the total quantity of bacteria in the sample will be measured by 
real-time quantitative PCR and expressed in picograms of bacterial DNA. Colony count measurements 
will be recorded in colony-forming units (CFU) per skin surface area, to the nearest whole number. 
 
10. 1 
Power analysis 
The study is powered. An important goal of this study is to determine the changes in severity score pre/post 
treatment based on a 5 point severity scale. As we expect a decrease in severity score based off IgA scale 
post-treatment, we powered the study based on the ability to detect at least a one point difference in change 
of severity score with 80% power and an alpha level of 0.05. 
 
11. POTENTIAL PITFALLS 
Potential pitfalls include participant bias and lack of diversity, as this pilot study is recruiting from one 
dermatology clinic. 
 
12. STUDY SITE 
Medical Dermatology Associates of Chicago 
363 W Erie Street, Suite 350 
Chicago, IL 60654 
 
Lincoln Park Outpatient Center  
2515 N. Clark Street 8th Floor, Suite 801  
Chicago, IL 60614-3393 


14 
 
 
Lurie Children’s Hospital 
225 E. Chicago 
Chicago, IL, 60611 
 
Northwestern University 
750 N. Lake Shore Dr, Suite 680 
Chicago, IL 60611 
 
Children’s Healthcare Associates 
2900 N Ashland Ave.  
Chicago, IL 60657 
 
13. ETHICAL CONSIDERATIONS 
13.1. Human Subjects Protection 


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A periodic review must be submitted to the IRB at least once a year. The IRB must be 
noticed of completion of the study. After study completion or termination, a final report must 
be provided to close the study. The investigator must maintain an accurate and complete record 
of all submissions made to the IRB, including a list of all reports and documents submitted. 
Adverse events will be submitted promptly to the IRB per IRB guidelines. 
At least once per year, the IRB must review and give written approval in order to continue 
the study. This trial will be conducted in accordance with Good Clinical Practices and the 
Declaration of Helsinki. 
 
13.2. Consent Forms 
Prior to study entry, a written informed consent and/or assent must be obtained from the 
subject or the subject’s guardian. A copy of the subject’s signed consent or assent form must be 
retained in the study file. 
 
13.3. Protocol Amendments 
All changes must be submitted to the IRB. Protocol modifications that impact subject safety 
or the validity of the study must be approved by the IRB before initiation. 
 
13.4. Retention of Records 
We will retain subject identification codes, subject files, and source data for the maximum 
period of time permitted by the hospital, institution, or private practice, but not less than 2 years 
after the completion or discontinuation of the trial. 
 
13.5. Use of Information and Publication 
The Principal Investigator and sub-investigators may publish the results of this study in 
conjunction will appropriate scientific and medical personnel. 
14. APPENDIX 
 
All the ingredients used in this study were ordered from manufacturers who have current 
good manufacturing practices. Additionally, all of the ingredients used in the treatment have been 
approved by the FDA. The bacteria is heat-killed in Dr. Seed’s lab and Dr. Mahdavinia’s lab at 
121°C (249 °F) for 15 minutes and be stored at room temperature away from other organisms to 
ensure sterility. Afterwards, the heat-killed bacteria will be added to the base, honey and turmeric 


16 
 
mixture in a sterile biosafety cabinet, separate from contaminants. To ensure batch safety, the 
mixture will be plated and observed to verify that nothing grows and all of the bacteria are dead. 
 


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