Effect of Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias
Phase: NA
Conditions: Lichen Planopilaris of Scalp, Alopecia Areata
Sponsor: University of Minnesota

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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Template Revised On: 03/31/2021 
ANCILLARY REVIEWS 
 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
☑ No 
 
Include Gillette resources, staff 
or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
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☐ No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
☑ Yes 
☐ No 
Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
 
See: 
https://policy.umn.edu/research/indide  
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sure? See guidance on next 
page. 
 
Documentation of scientific merit must 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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or synthetic nucleic acids, 
toxins, or infectious agents? 
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eprotocol.umn.edu 
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groups each 
have their 
own 
application 
process.  
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Include the use of human fetal 
tissue, human embryos, or 
embryonic stem cells? 
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instructions and guidance 
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requesting a HIPAA waiver? 
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prior to IRB 
approval. 
 
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process but 
additional 
information 
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study team 
may be 
required. 
 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 3 of 29 
Template Revised On: 03/31/2021 
Protocol Title 
Effect of mechanical intervention on the scalp microbiome: setting 
the stage for the future management of cicatricial alopecias 
Principal 
Investigator/Faculty 
Advisor 
Name: Ronda Farah, MD 
Department: Dermatology 
Telephone Number: (612) 625-8625 
Email Address: rfarah@umn.edu 
Co-investigator 
Name: Maria Hordinsky, MD 
Department: Dermatology 
Telephone Number: (612) 625-8625 
Email Address: hordi001@umn.edu 
Student Investigator 
Name: Nathalie Ly, BS 
Current Academic Status (Student, Fellow, Resident): 
Pre-Doctoral Research Fellow 
Department: Dermatology 
Telephone Number: ((920) 287-2775 
Institutional Email Address:ly000100@umn.edu 
Scientific Assessment 
I believe Scientific Assessment is required. 
IND/IDE # (if 
applicable) 
N/A (non-significant risk IDE) 
IND/IDE Holder 
N/A 
Investigational Drug 
Services # (if 
applicable) 
N/A 
Version 
Number/Date: 
Version 5 05 August 2023 
 
 
PROTOCOL COVER PAGE 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 4 of 29 
Template Revised On: 03/31/2021 
 
 
 
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
May 15 2022 
Change in number of 
treatments/duration of study 
Yes  
2 
September 13 
2022 
Addition of HairMetrix to secondary 
endpoint and study design 
Yes 
3 
January 4, 
2023 
Edit to HairMetrix to only occur 
before treatment and edited the 
frequency of control swabs to room 
air 
Yes 
4 
March 2, 2023 
-Changed age of enrollment eligibility 
to 18-50 years old  
- Administrative updates 
-On page 11-updated sentence to 
indicate the treatment is over a two-
week period. 
-Updated the section 5.3 page 12 that 
participation will last approximately 
2.5 weeks 
-Removed the words "before 
treatment" on page 13 
Yes 
5 
August 5, 2023 
-Changed total enrollment to “n=20-
25”, pg 10 
- Updated total enrollment to state “A 
total of up to 25 subjects” on pg 10 
-Deleted 20 males and 20 females on 
pg 10 
No 
 
 
 
 
 
 
 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 5 of 29 
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Table of Contents 
 
1.0 
Objectives 
7 
2.0 
Background 
7 
3.0 
Study Endpoints/Events/Outcomes 
9 
4.0 
Study Intervention(s)/Investigational Agent(s) 
9 
5.0 
Procedures Involved 
10 
6.0 
Data and Specimen Banking 
13 
7.0 
Sharing of Results with Participants 
14 
8.0 
Study Population 
14 
10.0 
Local Number of Participants 
16 
11.0 
Local Recruitment Methods 
17 
12.0 
Withdrawal of Participants 
18 
13.0 
Risks to Participants 
18 
14.0 
Potential Benefits to Participants 
19 
15.0 
Statistical Considerations 
19 
16.0 
Health Information and Privacy Compliance 
20 
17.0 
Confidentiality 
23 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Participants 
23 
19.0 
Provisions to Protect the Privacy Interests of Participants 
25 
20.0 
Compensation for Research-Related Injury 
25 
21.0 
Consent Process 
25 
22.0 
Setting 
26 
23.0 
Multi-Site Research: N/A 
27 
24.0 
Coordinating Center Research 
27 
25.0 
Resources Available 
27 
26.0 
Citations 
27 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 6 of 29 
Template Revised On: 03/31/2021 
 
ABBREVIATIONS/DEFINITIONS 
Abbreviation  
Word or Phrase 
Definition  
LPP 
 Lichen planopilaris  
An inflammatory condition that 
may cause scarring hair loss.   
AA 
Alopecia areata 
An autoimmune disease resulting 
in patches of hair loss.  
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 7 of 29 
Template Revised On: 03/31/2021 
1.0 
Objectives 
1.1 Purpose: The objective of this study is to assess the effect of standardized scalp 
care, specifically mechanical cleansing with the Venus Glow™ Device and water, 
on the scalp microbiome. This study also seeks to characterize the microbiome of 
the normal, healthy scalp, thereby providing a baseline for which the scalp 
affected by hair and scalp disease can be compared. 
2.0 
Background 
2.1 Significance of Research Question/Purpose: 
Perturbations in the epidermal ecosystem which interacts with the immune 
system have been shown to be associated with skin diseases including rosacea, 
folliculitis, seborrheic dermatitis/dandruff, and alopecia areata (AA)1. In the 
cicatricial alopecias such as folliculitis decalvans and lichen planopilaris (LPP), S. 
aureus is commonly isolated and treated.1 Why this bacteria is so commonly 
expressed in the cicatricial alopecias is not known. Furthermore, scalp hygiene 
practices, such as washing or shampooing, which may be influenced by an array 
of factors and are highly variable across populations,2,3 may play a role. There is 
little known about the effects of hygiene practices on the scalp microbiome, 
and much less about the microbiome of the scalp affected by cicatricial 
alopecias; thus, this information is needed to better understand the role of 
microorganisms, including S. aureus, in these conditions.  
The development and introduction of new devices, such as the Venus Glow™, 
provide a unique opportunity to fill a knowledge gap and discern the effects of 
scalp care and treatments on scalp health and scalp flora. This study will employ 
the Venus Glow™device, which is a FDA Class 1 device used for cosmetic 
treatments4 and is found mostly in medical spas and salons. It is marketed to 
rejuvenate skin by “cleaning pores of daily debris.”4  Treatment involves use of a 
lactic acid solution5 and a serum provided by the manufacturer. In this study, 
only water will be delivered; no serums will be added.  
Through the investigational use of the Venus Glow™ device, we propose that 
the technique of mechanical cleansing will change the scalp microbiome 
composition and will result in a clinically healthier scalp. 
2.2 Preliminary Data:  
Preliminary studies within our institution include a scalp swab assessment of 
participants with scarring alopecia compared to controls. The study thus far has 
found a predominance of Staphylococcus, Propionibacterium, and 
Auritidibacter in the frontal region of healthy control scalps. Additionally, one 
sample collected from a participant with dandruff had a greater proportion of 
Staphylococcus and a smaller proportion of Propionibacterium compared to 
samples, consistent with what has been reported in the literature (12,13,15,17).  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 8 of 29 
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2.3 Existing Literature:  
The scalp hosts a unique microbiome compared to other skin surfaces, with 
decreased acidity and decreased exposure to ultraviolet light.6-8 Many studies 
have assessed the scalp flora via swabs. The results of which are discussed 
below:  
Author 
Subjects 
Methods 
of 
Analysis 
Microbe Selection Process 
Results  
Shibagaki et 
al.9 
Healthy Japanese women- 
ages 21-37 (n=) v. over 60 (n=) 
Scalp 
Swab  
Species with ≥0.1% presence in >50% 
of the all subjects in at least one skin 
site 
Increased Proteobacteria, Klebsiella. and Prevotella in 
older group. 
Grice et al. 10 
Healthy humans (n=10) 
Occipital 
Scalp 
Swab  
19 bacterial phyla were detected, but 
most fall within the four phyla 
discussed 
Propionibacterium species and Staphylococci species 
were the most predominant. 
Xu et al. 11 
Volunteers with varying 
dandruff levels (n=59) 
Scalp 
Swab  
11 bacterial phyla, 123 genera, and 
378 operational taxonomic units of 
fungi were detected 
Propionibacterium and Staphylococcus were the most 
predominant bacteria in both groups. Decreased 
Propionibacterium, increased Staphylococcus, decreased 
M. globosa in the dandruff group.  
Soares et 
al.12 
Dandruff (n=13) v. healthy 
controls (n=11) 
Vertex 
Scalp 
Swab 
274 fungal OTUs were detected, plant 
sequences were removed. 612 
bacterial OTUs were detected, 
chloroplasts and mitochondria 
sequences were removed 
Propionibacterium,Staphylococcus, and 
Corynebacterium were most predominant in both 
groups. M. restricta was the most predominant fungi in 
both groups. Increased Pseudomonas, Leptotrichia, 
Micrococcus, Selenomonas, Erwinia, Enhydrobacter, 
Bartonellaceae, Candida, Aspergillus, and Filobasidium in 
dandruff group.  Decreased Propionibacterium in 
dandruff group.  
Clavaud et al. 
13 
Dandruff v. healthy controls 
Scalp 
Swab 
DNA from 3 major species was 
extracted. 
Propionibacteria and Staphylococci were the most 
predominant bacteria in both groups. M. restricta was 
the most predominant fungi in both groups. Decreased 
P. acnes, increased M. restricta, and increased S. 
epidermidis in dandruff group.  
Wang et al. 
14 
Dandruff (n=32) v. non-
dandruff controls (n=9) 
Scalp 
Swab 
2,195 bacterial and 1,818 fungal 
sequences were detected 
P. acnes and S. epidermidis dominated both groups. M. 
restricta was the most predominant fungi in both groups. 
Increased M. restricta and Staphylococcus spp. in 
dandruff group. No significant difference in 
Propionibacterium between groups. 
Grimshaw et 
al. 15 
Dandruff (n=32) v. healthy 
controls (n=9) 
Scalp was 
exfoliated 
and 
resulting 
scale in 
saline was 
analyzed  
Discussed the 8 predominant taxa 
from 273 fungal OTUs. Discuss the 
most predominant taxa from 300 OTUs 
 
Malassezia was the most predominant species in both 
groups and higher in the dandruff group. 
Staphylococcus and Cutibacterium were the most 
predominant bacteria in both groups. Non-significant 
decrease in Cutibacterium and increase in 
Staphylococcus in dandruff groups.  
Saxena et al. 
16 
Dandruff (n=70) v. healthy 
controls (n=70) 
Vertex 
Scalp 
Swab 
Species with ≥1% abundance in ≥20 
samples were analyzed 
M. globose and M. restricta were the most predominant 
fungi in both groups. No difference in M. restricta 
abundance between groups. Increased M. globose in the 
healthy scalp. Increased S. epidermidis in dandruff 
group. No difference in P. acnes abundance between 
groups.  
 
Park et al. 17 
Dandruff (n=28) and 
seborrheic dermatitis Korean 
subjects (n=29) v. Korean 
controls (n=45) 
Vertex 
Scalp 
Swab 
56 bacterial OTUs that had abundance 
>0.05% and 39 fungi species with 
abundance >0.01% were analyzed 
Increased Staphylococcus sp. and M. restricta in dandruff 
and seborrheic dermatitis groups. Increased 
Propionibacterium sp. and M. globosa in control group.  
Lin et al. 18 
Dandruff (n=28) and 
erythemal scalp Chinese Han 
subjects (n=29) v. Chinese Han 
controls (n=53) 
Scalp 
swab from 
lesion and 
healthy 
sites 
The 8 most predominant fungi and 
bacteria genera were discussed.  
No difference in P. acnes abundance between groups. All 
groups had the same predominant microbes including: 
Malassezia, Aspergillus, Exophiala, Aureobacsidium, 
Phaeoacremonium, Lecanicillium, Cyberlindnera, 
Debaryomyces, Staphylococcus, Sediminibacterium, 
Corynebacterium, Pseudomonas, Phyllobacterium, 
Bardyrhizobium, Sphingomonas, and Bosea. 
Juhasz et 
al.19 
AA (n=25) v. healthy controls 
(n=25) 
Scalp 
Swap 
Not discussed.  
Decreased Firmicutes and increased Actinobacteria in AA 
groups.  
Constantinou 
et al.20 
Frontal fibrosing 
alopecia (FFA) (n=6)  v.  lichen 
planopilaris (LPP) (n=6) v 
Scalp 
Swap 
Five most abundant genera across 
samples were analyzed.  
Increased Staphylococcus in disease lesions in all 
alopecia participants. Increase in Staphylococcus in non-
lesional sites in participants with LPP. 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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alopecia areata circumscripta 
(AAc) (n=7) 
Pinto et al.21 
AA (n=15) v. healthy controls 
(n=15) 
Scalp 
Swab  
Not discussed. 
Increased P. acnes, decreased S. epidermidis in AA 
group. No difference in S. aureus abundance between 
groups.  
 
 
No studies have assessed the use of the Venus Glow™ device on the scalp and 
no studies have assessed the different scalp regions, such as the vertex, 
temporal and postauricular scalp, systematically.  
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: The primary endpoint will be scalp swab 
assessment of scalp microbiome composition before and after Venus Glow™  
treatment. Our hypothesis is that there will be a decrease in microbe burden on 
the scalp with treatment.  
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): Secondary endpoint includes scalp 
swab assessment of scalp microbiome composition after participants have 
returned to their normal hair and scalp care routine, providing information about 
the normal, healthy scalp microbiome. In addition, photography comparisons 
with the HairMetrix device will be taken before each treatment at the swab sites 
for each participant. 
  
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 Description: 
Venus Glow™device is an FDA Class 1 device used for cosmetic treatments4. The 
device utilizes hydradermabrasion to clean and remove debris from the skin. 
Hydradermabrasion is a form of microdermabrasion that utilizes a crystal-free 
exfoliation tip with water and often a method for suction.22,23 To complete such 
treatment, the Venus Glow™ device employs a hand-piece functional with a 
rotating tip, two 70-micron jets, and a vacuum.4 The rotating tip and jets allow 
for dispersion of a selected solution to clean and the vacuum allows for removal 
of debris via the suction.  
Our off-label design utilizes the Venus Glow™device, but with device setting 
adjustments optimized for scalp health. The device will be set to the weakest 
injection setting (setting 1) given we are not injecting serums and intend to wet 
only the scalp, not the hair fibers. The suction will be set to the maximum 
setting (setting 3) to allow for ample removal of debris. No sensitivity or adverse 
events such as bruising have been seen when using this setting on the scalp. 
Finally, the rotation will be set to the medium setting (setting 2) to allow for a 
moderate cleansing without unnecessary exfoliation. 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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We believe this device may be a non-significant risk device as it: 
● is not an implant and does not present a potential for serious risk to the 
health, safety, or welfare of a participant;  
● is not purported and will not be represented to be for use supporting or 
sustaining human life and presents a potential for serious risk to the 
health, safety, or welfare of a participant;  
● will not be used of substantial importance in diagnosing, curing, 
mitigating, or treating disease, or otherwise preventing impairment of 
human health and does not present a potential for serious risk to the 
health, safety, or welfare of a participant; or  
● does not otherwise pose a potential for serious risk to the health, safety, 
or welfare of a participant.  
4.2 Drug/Device Handling:  
The off-label Venus Glow™device will be stored in the University of Minnesota 
Department of Dermatology in the Phillips-Wangensteen building, Maple Grove 
clinic or the Clinics and Surgery Center. Additional supplies will be stored 
separately in the respective clinics.  
While wearing gloves, the device and treatment room will be wiped down with 
disinfectant wipes after each use. The handpiece tips will be changed in 
between each subject visit. Gloves and masks will be utilized by the study staff 
that is administering the treatment. Participants will be asked to follow the 
current CDC guidelines regarding COVID-19.  
4.3 Biosafety: N/A - The research does not involve a recombinant or synthetic nucleic 
acid, human gene transfer, biologically derived toxin, or an infectious agent. 
4.4 Stem Cells: N/A - The research does not involve stem cells.  
4.5 Fetal Tissue: N/A - The research does not involve fetal tissue.  
 
5.0 
Procedures Involved 
5.1 Study Design: This is a research study utilizing scalp swabs to evaluate the efficacy 
of the Venus Glow™device treatment on the scalp microbiome. Healthy 
participants who have not been diagnosed with scalp or hair disease will be 
followed over a period of 2 weeks to assess their scalp microbiome and see how 
well the investigational device works on decreasing the microbe burden of the 
scalp.  
Total Enrollment (N= 20-25): A total of up to 25 subjects between the ages of 
18-50 years with different self-reported ethnicities and evaluated skin and hair 
types will be enrolled in the study.  
5.2 Study Procedures:  

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PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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Subjects will come for Venus Glow™ treatments, two treatments over a two 
week period. At the first visit they will complete an initial questionnaire 
regarding current scalp care practices, skin type, and hair type. An initial 
baseline scalp swab and HairMetrix photography in the two swab sites will be 
taken at the beginning of this visit. Treatment with the Venus Glow™ device will 
also occur. To treat, the scalp will be divided into four quadrants. In the right 
two quadrants, the hair will be sectioned into both vertical and horizontal parts 
about 1 cm apart. The tip of the device will then be dragged in zig zag 
movements along vertical part widths, then along horizontal part widths, and 
then once more along the vertical part widths, to account for a total of three 
passes. The left side will not be treated with the device.  
Swab samples will be collected from the untreated right mid-frontal 
scalp, treated right mid-frontal scalp, and the untreated left mid-frontal 
scalp and will be collected at the first baseline and concurrent treatment 
session, second treatment session and 3-6 days after the last treatment 
when participants have returned to their usual cleansing routine. In 
addition, HairMetrix photography will be taken in the two swab sites 
(right scalp swab site and left scalp swab site) before treatment at the 
first baseline and concurrent treatment session, the second treatment 
session and the follow-up session 3-6 days after the last treatment.  
All swabs will be taken 10 cm from the nasal bridge and 3 cm from the midline (see 
Photo 1 below). Subjects will avoid shampooing, chemical, or heat treatments, 
but will be able to wet their hair during the study. 
Photo 1: Swab Sites (25) 
 

MEDICAL PROTOCOL (HRP-590) 
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stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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To collect samples, sterile cotton swabs will be soaked for at least 30s in 
collection buffer (0.15 M NaCl, 0.1% Tween-20) and rubbed on the scalp surface 
in the following locations: right and left mid-frontal scalp, covering an area of 4 
cm2 per scalp section. Swabs will be stored in a collection buffer amended to a 
final concentration of 10% glycerol and stored at -80 °C prior to 
shipping/processing. If necessary, samples will be shipped to the microbiology 
lab on dry ice. Control swabs exposed to just room air and the buffer will be 
collected throughout the course of the study when treating participants. DNA 
will be extracted from the swab tips using the Daisy PowerSoil Pro DNA isolation 
kit (QIAGEN). Bacteria/archaea will be characterized by amplification and 
sequencing using the 515F/806R primer set targeting the V4 hypervariable 
region of the 16S rRNA gene. 25 Fungal communities will be characterized by 
sequencing of the ITS1 region using the ITS1f/ITS2 primer set. 26 Paired-end 
sequencing will be carried out at a read length of 300 bp on the Illumina MiSeq 
platform by the UMN Genomics Center. Bioinformatics and computational 
analyses of microbiome data will be done by the Staley lab using mothur 
software and raw data will be made publicly available on the Sequence Read 
Archive. 
5.3 Study Duration: The total duration of participant participation will be 
approximately 2.5 weeks. The duration anticipated to enroll all study participants 
is expected to be approximately 5 months. It is anticipated that it will take just 
over 1 years to complete all study procedures including data analysis. 
Week 0 - Baseline/First 
Treatment  
 
● Consenting and enrollment 
● Demographic information 
● Medical history 
● Subjects to complete a questionnaire about 
current scalp care practices, skin type, and hair 
type, including: 
o Number of days prior to last shampooing  
o Names of products that they have used 
on their hair/scalp since their last 
shampoo (oils, sprays, gels, etc.)  
o Average frequency of shampooing per 
week  
o Average frequency of hair styling with hot 
tools per week  
o Hair type I-VIII (Loussouarn et al.)24 
o Fitzpatrick Skin Type 

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PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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● Swab of right and left mid-frontal scalp prior to 
treatment 
● HairMetrix photography before treatment 
● Right side of scalp treatment with the Venus 
Glow™ device and brush (left side will not be 
treated) 
● Swab of right mid-frontal scalp post- treatment  
Beginning of Week 1 - Second 
Treatment 
(+/- 3 days) 
● Participant report of adverse events 
● Swab of right and left mid-frontal scalp prior to 
treatment  
● HairMetrix photography before treatment 
● Right side of scalp treatment with the Venus 
Glow™ device and brush (left side will not be 
treated) 
● Swab of right mid-frontal scalp post-treatment  
End of Week 1- Final Visit (+/3 
days) 
● Participant report of adverse events 
● Swab of right and left mid-frontal scalp  
● HairMetrix photography  
 
 
All participants will have a final 3-6 day visit and swab collection after their treatments 
have been completed and they have returned to their typical hair and scalp care 
routine, described above. All visits including this final visit will be compensated at $10 
per visit. If a patient happens to miss a study visit, one of the study staff will reach out 
to the patient via a phone call.  
5.4 Use of radiation: N/A 
5.5 Use of Center for Magnetic Resonance Research: N/A 
6.0 
Data and Specimen Banking 
6.1 Storage and Access: Deidentified data may be banked in the University’s Box 
Secure Storage or REDCap database.  
6.2 Data: Deidentified data may be banked for future analyses and compilation into 
larger datasets, such as clinical and demographic information and clinical 
assessments and rating scales.  

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6.3 Release/Sharing: Deidentified data from this study may be used in the future to 
compile larger datasets from multiple studies with similar methodologies and 
populations to conduct additional analyses and publications. Should the 
investigators pursue this, future studies seeking to compile data acquired from 
this protocol will obtain IRB approval before doing so. In the event that this 
occurs, only investigators or study personnel listed in an IRB-approved protocol 
pertaining to the data compilation will have access to this data.  
7.0 
Sharing of Results with Participants 
7.1 The individual results of the study will not be shared with participants or others. 
Deidentified data will be compiled, analyzed, and summarized for journal 
publication and/or poster presentations.  
7.2 Sharing of genetic testing:  
7.2.1 Disclosure of results: N/A 
7.2.2 If returning results to participants: N/A 
● Aggregate or individual results: N/A 
● Laboratory results: N/A 
● Plan for return of results to participants: N/A 
● Types of results to be returned to participants: N/A 
7.2.3 Future analysis of genotypes: N/A 
8.0 
Study Population 
8.1 Inclusion Criteria:  
 
Participants must meet all of the inclusion criteria.  
● All individuals between 18-35 years of age 
● Ability to understand study procedures and to comply with them 
8.2 Exclusion Criteria:  
All candidates meeting any of the exclusion criteria at baseline will be excluded 
from participation in this study.  
● Non-English speakers 
● Exclusion related to pregnancy, lactation, or has plans to become 
pregnant over the course of the study  
○ Based on self-report from the participant   
● Current scalp or hair disease diagnosis  
● Using oral or topical antimicrobial medication 4 weeks prior to their 
baseline visit or in the duration of the study 

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● Current clinical condition that, in the opinion of the site investigator, 
would interfere with adherence to study requirements 
● Inability or unwillingness of individual to give written informed consent 
8.3 Screening: Adult healthy subjects in the Department of Dermatology at the M 
Health Fairview Clinics and Surgery Center or M Health Fairview Maple Grove 
Clinic will be approached to determine their interest in the study. Dermatologists, 
Dr. Hordinsky and Dr. Farah, will identify healthy subjects that may benefit from 
scalp cleansing. The study will be introduced after the healthy subjects’ clinical 
visit and contact information will be provided if they are interested. Participants 
may self-refer if they become aware of the study through recruitment materials 
or word of mouth referrals. Individuals who respond to the recruitment materials 
will be taken through a phone screening questionnaire. Interested healthy 
subjects will be screened for eligibility using the inclusion and exclusion criteria 
and written informed consent will be obtained from eligible healthy subjects at 
the baseline visit. Following the screening process, the healthy subjects will be 
seen for their baseline/first treatment visit (see section 5.3 for an outline of study 
procedures that occur at the baseline visit).  
9.0 
Vulnerable Populations 
9.1 
Vulnerable Populations:  
Population / Group 
Identify whether any of the following 
populations will be targeted, included 
(not necessarily targeted) or excluded 
from participation in the study.  
Children 
No 
Pregnant women/fetuses/neonates 
No 
Prisoners 
No 
Adults lacking capacity to consent 
and/or adults with diminished capacity 
to consent, including, but not limited 
to, those with acute medical conditions, 
psychiatric disorders, neurologic 
disorders, developmental disorders, 
and behavioral disorders 
No 
Non-English speakers 
No 
Those unable to read (illiterate) 
No 
Employees of the researcher 
No 

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Students of the researcher 
No 
Undervalued or disenfranchised social 
group 
Included / not targeted  
Active members of the military (service 
members), DoD personnel (including 
civilian employees) 
Included  
Individual or group that is approached 
for participation in research during a 
stressful situation such as emergency 
room setting, childbirth (labor), etc. 
No 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Included / not targeted  
Individual or group with a serious 
health condition for which there are no 
satisfactory standard treatments. 
No 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
No 
Any other circumstance/dynamic that 
could increase vulnerability to coercion 
or exploitation that might influence 
consent to research or decision to 
continue in research. 
No 
 
9.2 Additional Safeguards: Undervalued or disadvantaged people may not be known, 
research staff will not be asking a direct question about socioeconomic status to 
potential participants. We do not anticipate the vulnerability for this group to be 
increased by participating in this study. Additionally, members of the military may 
not be known, as research staff will not be asking a direct question about military 
status to potential participants. We do not anticipate the vulnerability for this 
group to be increased by participating in this study. 
 
10.0 
Local Number of Participants 

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10.1 Local Number of Participants to be Consented: 40 participants are needed for 
data analysis and we anticipate needing to consent 55 people to reach that goal.  
11.0 
Local Recruitment Methods 
11.1 Recruitment Process:  
If a potential participant is identified at the Department of Dermatology at the 
University of Minnesota Clinics and Surgery Center or Maple Grove Clinic, the 
attending provider will briefly introduce the study and ask if a member of the 
study team may come in to talk with them. If the potential participant agrees, 
the investigator and/or study coordinator will describe the study in detail, 
answer any questions the potential participant may have and describe next 
steps. All investigators and study staff will be trained in privacy and 
confidentiality requirements for conducting research at Fairview facilities. 
Patients who have opted out of research in their medical record will only be 
approached by clinical staff.  
Additionally, public recruitment will be done via the use of flyers in buildings on 
the University of Minnesota campus. These buildings could include academic 
buildings, student residences, athletic facilities, and student dining/recreation 
buildings. The study will also be posted on the University of Minnesota 
Department of Dermatology website: 
https://med.umn.edu/dermatology/research/clinical. Additionally, we will 
attach a PDF of the flyer to email to be sent out to the Dermatology Interest 
Group listserv.  
Participants may self-refer if they become aware of the study through these 
recruitment materials or word of mouth referrals. Individuals who respond to 
the recruitment materials will be taken through a phone screening 
questionnaire. If following the phone screen the potential participant is eligible 
and interested, the study coordinator will schedule the screening study visit.  
11.2 Identification of Potential Participants: Potential participants will be identified by 
the investigators from among patients under their care. Investigators will make 
the initial contact with potential participants at the time of their clinic visit.  
11.3 Recruitment Materials: Public recruitment will be done via the use of flyers that 
include the study and contact information. Tabs will be available at the bottom of 
the flyer to take if interested. Flyers will be posted in buildings on the University 
of Minnesota campus. These buildings could include the Malcolm Moos Health 
Sciences Tower, Phillips-Wangensteen building, Molecular and Cellular Biology 
building, and Jackson Hall.  
11.4 Payment:  
● Subjects will be given compensation for engagement in the study. Total 
compensation for subjects is $30.00. Subjects will receive $10.00 per 

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visit including the first baseline and concurrent treatment visit, one 
additional treatment visits, and one follow up visit.  
● Parking will be provided for all subjects who elect to participate at the 
Department of Dermatology at the University of Minnesota in the 
Phillips-Wangensteen building or Clinics and Surgery Center . The study 
will be completed at the University of Minnesota Department of 
Dermatology in the LCRU space, Maple Grove clinic or the Clinics and 
Surgery Center. Parking vouchers for the Oak Street patient visit parking 
ramp will be provided to participants at each in-office visit. Parking at 
the Maple Grove clinic is free of charge and thus parking vouchers will 
not be provided if the participants elects to participate at that location.  
 
12.0 
Withdrawal of Participants 
12.1 Withdrawal Circumstances: Participation in this study is voluntary. Participants 
are free to withdraw at any time. Investigators may also withdraw participants 
from the study if participants fail to adhere to the study protocol requirements. 
Possible withdrawal circumstances may also include: the participant no longer 
meets the inclusion/exclusion criteria, the participant is lost to follow-up, or it is 
in the participant’s best interest to withdraw from the study, as determined by 
the PI.  
12.2 Withdrawal Procedures: Data collection of withdrawn participants will be 
collected up to the point of withdrawal. Data from withdrawn participants will 
not be included in the analysis.  
12.3 Termination Procedures: This study may be suspended or prematurely 
terminated if there is sufficient reasonable cause. If the study is prematurely 
terminated or suspended, the PI will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension. The study team will also notify the 
participants of the study termination. Data will not be used after termination. 
Circumstances that may warrant termination or suspension include, but are not 
limited to: 
● Determination of unexpected, significant, or unacceptable risk to 
participants 
● Demonstration of efficacy that would warrant stopping 
● Insufficient compliance to protocol requirements 
● Data that are not sufficiently complete and/or evaluable 
● Determination of futility 
13.0 
Risks to Participants 
13.1 Foreseeable Risks:  
Potential risks include scalp irritation, redness, headache, itching, tingling, and 
abrasion of the skin.  

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Privacy/Confidentiality Risks: There is always the slight risk of loss of 
confidentiality of the medical record information and associated privacy of the 
participants. These risks will be minimized by storing data securely as per UMN 
institutional guidelines and limiting access to information contained within the 
registry to trained UMN investigators and members of the research team.  
13.2 Reproduction Risks: N/A 
13.3 Risks to Others: N/A 
14.0 
Potential Benefits to Participants 
14.1 Potential Benefits: Participants may experience an improvement in scale and/or 
oiliness of the scalp. Additionally, society and investigators will benefit from the 
knowledge gained. 
15.0 
Statistical Considerations 
15.1 Data Analysis Plan:  
The primary analysis will evaluate whether there is a difference in the baseline 
and 2-week change in the relative abundance of pre-specified bacteria (approx. 
20) between the device-treated portion of the scalp and the non-treated portion. 
In order to account for the within-subject correlation, mixed-effects models will 
be performed. As a secondary analysis, we will compare the HairMetrix images 
and analyze how various demographic and clinical factors such as sex and skin 
type impact the effect of the device.  
15.2 Power Analysis:  
Limited data are available to inform a power/sample size estimate. However, if 
there is a total of 38 subjects (40 initial, with 5% dropout), then we will have pre- 
and post-treatment data for 38 device-treated, and 38 non-treated portions of 
the scalp. Even when ignoring the within-subject correlation, this will allow us to 
have 80% power to detect an effect size of 0.7 (difference in the baseline to week 
1 change between groups), assuming an alpha of 0.05. 
15.3 Data Integrity:  
● The study monitor will ensure that the investigation is conducted according to 
protocol design and regulatory requirements. The monitor will provide ongoing 
monitoring of data validity and regulatory issues (e.g., eligibility determinations, 
consent form process, serious adverse event reporting, IRB actions, disclosures 
of conflict of interest). 
● Study records will be monitored at regular intervals by the study monitor. The 
monitor will perform source data verification and as such must be given access 
to the subject’s primary source documentation, such as paper or electronic 
medical records such as consent to participate in the study, visit dates, 
demographic information, adverse events, concomitant medications, drug 
accountability, etc. that support data entries in the CRF. 

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● The PI will be provided copies of monitoring reports shortly after the monitoring 
visit. Findings will be noted and followed up in the subsequent monitoring visit. 
16.0 
Health Information and Privacy Compliance 
16.1 
Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
 
☑ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the 
U of M stand-alone HIPAA Authorization.  Note: External IRB must be serving 
as the privacy board for this option. 
 
16.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI 
(also referred to as the University's Information Exchange (IE) or data 
shelter) to pull records for me 
☑ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.   
16.3 
Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed. 
Patients who have opted out of research in their medical record only be 
approached by clinical staff to assess interest in participation in the study.  

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16.4 
Approximate number of records required for review: N/A 
16.5 
Please describe how you will communicate with research participants during 
the course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication 
with research participants. 
☑ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.   
☑ Communication with research participants will take place outside of 
treatment settings. If this box is selected, please describe the type of 
communication and how it will be received by participants.  
Participants may self-refer if they become aware of the study through 
these recruitment materials or word of mouth referrals. Individuals who 
respond to the recruitment materials will be taken through a phone 
screening questionnaire. 
16.6 
Explain how the research team has legitimate access to patients/potential 
participants: 
If a potential participant is identified at the Department of Dermatology at the 
University of Minnesota Clinics and Surgery Center or Maple Grove Clinic, the 
attending provider will briefly introduce the study and ask if a member of the 
study team may come in to talk with them. If the potential participant agrees, 
the investigator and/or study coordinator will describe the study in detail, 
answer any questions the potential participant may have and describe next 
steps. All investigators and study staff will be trained in privacy and 
confidentiality requirements for conducting research at Fairview facilities. 
16.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☑ In REDCap (recap.ahc.umn.edu)  
 ☑ Store 
☑ Analyze 
☑ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 

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☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☑ In the University’s Box Secure Storage (box.umn.edu) 
 ☑ Store 
☑ Analyze 
☑ Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In an AHC-IS supported desktop or laptop. Provide UMN device numbers of all 
devices:  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ Other. Describe:  
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet 
computer such as an iPad or a smartform (iPhone or Android devices) that you 
have not already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
16.8 Consultants. Vendors. Third Parties: N/A 
16.9 Links to identifiable data: All data will be identified with an identification code 
unique to the participant. Study staff will keep the mapping of identification code 
to the identity of the participant on an encrypted password protected computer 
stored separately from the data in the University’s Box Secure Storage. That same 
identification code will be used for data-entry into the REDCap database. Any 
internal data reports will use only these codes and will not use any identifiable 
information. Any external data reports, abstracts, publications, presentations, etc. 
will present de-identified, grouped, and/or aggregate data. Any reports to the 
University of Minnesota IRB (such as Adverse Event reporting and annual renewal 
reports) will be kept confidential; they will not include participant- identifiable 
information; only the participant’s identification code will be used. 
 

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16.10 Sharing of Data with Research Team Members: Only IRB-approved members of 
the study team will have access to the data. Data will be shared through 
REDCap or the University’s Box Secure Storage.  
 
16.11 Storage and Disposal of Paper Documents: This study will not require the use of 
paper documents. All documents will be stored electronically via the REDCap 
database or the University’s Box Secure Storage. Consent forms will be signed 
and stored in REDCap.  
17.0 
Confidentiality 
17.1 Data Security: Only research staff will have access to subject information. All 
participant data will be stored in locked cabinets and electronically in REDCap. 
Passwords will be required to access data in REDCap. Study data will be available 
only to select staff that need access to the information to conduct their research 
duties. To minimize the volume of documents containing identifying information, 
all study documents or data will contain a unique participant ID that will be used 
when possible. No copy of the consent form or other research study information 
will be placed in the participant’s medical, employment, or educational records. 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Participants 
18.1 Data Integrity Monitoring:  
Independent monitoring of the clinical study for clinical protocol and IND/IDE 
application compliance will be conducted by the University of Minnesota’s 
Clinical and Translational Science Institute (CTSI) clinical trial monitoring service. 
The CTSI monitors will confirm that study activities are in compliance with the 
approved protocol and applicable regulatory authorities (FDA, IRB, local and 
State regulations). Frequency of monitoring visits will occur after IRB approval 
and as soon as possible after the first subject is enrolled, during the study data 
collection phase and after the last subject has completed his/her participation 
in the study.  Monitoring visits will be performed annually, at a minimum. This 
monitoring schedule may be revised based on the following considerations: 
● Accrual rate 
● Protocol deviations or non-compliance with regulatory 
authorities 
● Magnitude of data corrections required 
● Study stage (e.g. start-up or follow-up) 
● Complexity of the trial 
● Request (IRB, Investigator, other etc.) 
The sponsor-investigator will permit direct access to the study monitors 
and appropriate regulatory authorities to the study data and to the 
corresponding source data and documents to verify the accuracy of these 
data. 

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Primary responsibilities of the monitors will include verifying the 
following: 
● Investigator qualifications 
● Facilities and equipment 
● Storage, dispensing and disposition of investigational products 
● Protocol compliance 
● Informed consent 
● Training and delegation of authority 
● Subject eligibility 
● Recruitment, screening and enrollment 
● Verification of data and data clarification 
● Adverse event reporting 
● FDA correspondence 
● Deviations 
18.2 Data Safety Monitoring:  
The investigators will ask participants about adverse events at each of the 
follow-up study visits. Participants are encouraged to call in if they experience 
any adverse events prior to that time. Study progress and safety will be 
reviewed monthly (and more frequently if needed) by the PI. The PI will review 
patient safety data monthly and determine if adverse event rates are consistent 
with pre-study assumptions, or if there is an increased rate of risk or new 
information that should be shared with enrolled participants. If a serious 
adverse event (SAE), Unanticipated Problem Involving Risks to Subjects or 
Others (UPIRTSO), or other event causing risk to the research subjects occurs, 
the clinical research team will notify the PI immediately. The PI will assure the 
study is conducted in accordance with the investigator’s agreement, the 
investigational plan, the IDE and other applicable FDA regulations, and 
conditions of approval imposed by the reviewing IRB. 
All AEs will be assessed by the study investigators using a protocol defined 
grading system. 
● Mild – Events require minimal or no treatment and do not interfere with 
the participant’s daily activities.  
● Moderate – Events result in a low level of inconvenience or concern with 
the therapeutic measures. Moderate events may cause some 
interference with functioning. 
● Serious – Events interrupt a participant’s usual daily activity and may 
require systemic drug therapy or other treatment. Severe events are 
usually potentially life-threatening or incapacitating. 
● Related – The AE is known to occur with the study intervention, there is 
a reasonable possibility that the study intervention caused the AE, or 

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there is a temporal relationship between the study intervention and 
event. Reasonable possibility means that there is evidence to suggest a 
causal relationship between the study intervention and the AE. 
● Not Related – There is not a reasonable possibility that the 
administration of the study intervention caused the event, there is no 
temporal relationship between the study intervention and event onset, 
or an alternate etiology has been established. 
The Principal Investigator will be responsible for determining whether an 
adverse event (AE) is expected or unexpected. An AE will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the study intervention. 
19.0 
Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy: The study consent form will describe in detail any intrusive, 
uncomfortable, or unfamiliar questions, procedures, or interactions with 
researchers or study personnel that the participant will be asked to complete. 
Furthermore, the study consent form will communicate that it is the participant’s 
right to opt-out of any study procedures for the study or withdraw from the study 
at any time and this information will be reiterated and revisited periodically 
throughout the study in advance of intrusive, uncomfortable, or unfamiliar 
questions, procedures, or interactions. Participants will not be compelled or 
pressured to provide information or specimens or study data that they do not 
wish to provide. 
19.2 Access to Participants: Participants will be fully informed of the ways in which 
their data will/may be used during the informed consent process. The research 
team has been trained in conducting these conversations and the participants are 
also assessed for their understanding of consent prior to signing the consent form 
or initiating any study procedures. 
20.0 
Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: If this research activity results in an 
injury, treatment will be available, including first aid, emergency treatment and 
follow-up care as needed.  Care for such injuries will be billed in the ordinary 
manner, to the participant or his/her insurance company. 
20.2 Contract Language: N/A 
21.0 
Consent Process 
21.1 Consent Process (when consent will be obtained):  
The consent process will take place in a private room at the University of 
Minnesota Department of Dermatology in the Phillips-Wangensteen building,  
Maple Grove clinic or the Clinics and Surgery Center. If a patient meets the 

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criteria via the phone screening, we will consent the patient at their baseline visit 
in person. Informed consent is a process that is initiated prior to the individual 
agreeing to participate in the study and continues throughout the individual’s 
study participation. Extensive discussion of risks and possible benefits of 
participation will be provided to the participants. REDCap eConsent forms will be 
approved by the IRB, and the participant will be asked to read and review the 
document using a tablet provided by the investigator. The investigator will explain 
the research study to the participant and answer any questions that may arise. All 
participants will receive a verbal explanation in terms suited to their 
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 
participant will be asked to sign the informed consent document or electronically 
sign using the HIPAA compliant REDCap eConsent, prior to any procedures being 
done specifically for the study. The participants may withdraw consent at any 
time throughout the course of the trial. A copy of the informed consent 
document will be given to the participants for their records. 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. 
21.2 Waiver or Alteration of Consent Process (when consent will not be obtained): N/A 
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed 
consent will not be obtained): We are requesting a waiver of written/signed 
documentation of consent for the screening portion of this study. A short phone 
script will be read to the participant before any screening questions are asked. 
The participant will need to provide verbal consent to answering these screening 
questions before proceeding. See attached for the screening phone script.  
21.4 Non-English Speaking Participants: N/A 
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years 
of age): N/A 
21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: N/A 
21.7 Adults Unable to Consent: N/A 
22.0 
Setting 
22.1 Research Sites: Participants will be recruited from the University of Minnesota 
Maple Grove clinic and the University of Minnesota Clinics and Surgery Center. All 
study procedures will take place at the University of Minnesota Department of 
Dermatology in the Phillips-Wangensteen building, Maple Grove clinic, or the 
University of Minnesota Clinics and Surgery Center.  

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 27 of 29 
Template Revised On: 03/31/2021 
22.2 International Research: N/A 
23.0 
Multi-Site Research: N/A 
 
24.0 
Coordinating Center Research 
24.1 Role: N/A 
24.2 Responsibilities: N/A 
24.3 Oversight: N/A 
24.4 Collection and Management of Data: N/A 
 
25.0 
Resources Available 
25.1 Resources Available:  
● 
The dermatology research interns/fellows will be participating in study 
procedures with the support of the PI. No students will be involved in this 
study.  
● 
The number of recruitable participants is appropriate for the time period of 
three years. Forty participants are needed for data analysis and we 
anticipate needing to consent 55 people to reach that goal.  
● 
One to two hours of PI/study staff time will be dedicated to each visit.  
● 
Facilities for this study include the M Health Fairview Maple Grove Clinic, M 
Health Fairview Clinics and Surgery Center, and the clinical research room in 
the University of Minnesota Department of Dermatology.  
● 
There are no anticipated severe consequences of the treatment, however, 
two of the sites are in the clinical setting and one is connected to the UMMC 
Hospital.  
● 
The PI or Co-PI will be present for all treatments, in addition to dedicated 
dermatology research staff.  
 
26.0 
Citations  
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Effect of mechanical intervention on the scalp microbiome: setting the 
stage for the future management of cicatricial alopecias 
 
VERSION DATE: 05 August 2023 
 
Page 29 of 29 
Template Revised On: 03/31/2021 
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