Effect of Cream Paste Containg Pleuran (β-glucan From Pleurotus Ostreatus) on Selected Skin Dermatoses.
Phase: NA
Conditions: Diaper Dermatitis, Perioral Dermatitis, Neonatal Pustulosis, Periorificial Dermatitis, Erythema
Sponsor: Pleuran, s.r.o.

ECESID study protocol version 2_04/2024 
Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) on 
selected skin dermatoses.  
ECESID study 
Protocol of biomedical study 
Basic Information about Research: 
Title of Research: 
Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) 
on selected skin dermatoses. 
Acronym: 
ECESID 
Principal Investigator 
and Facility name: 
1MUDr. Karolína Vorčáková, PhD., Dermatovenerologická klinika, Univerzita 
Komenského v Bratislave, Jesseniova lekárska fakulta v Martine, UN Martin,  
Kollárova 2, 036 59 Martin, karolina.vorcakova@gmail.com  
Investigators and 
Facility names: 
2MUDr. Andrea Gelienová, Všeobecná ambulancia pre deti a dorast, Dr. 
Jásenského 478, 965 01 Žiar nad Hronom, tel. 045/ 672 68 29, 
gelienova@gelienova.sk  
3MUDr. Anna Kováčová, Všeobecná ambulancia pre deti a dorast, Bernolákova 
24, 953 01 Zlaté Moravce,  tel. 0905 850 112 
4MUDr. Beáta Nemčoková, Všeobecná ambulancia pre deti a dorast, 
Roosveltova 18, 040 01 Košice,  tel. 0905 384 067, nemcokova@netkosice.sk  
5MUDr. Jana Karľová, Všeobecná ambulancia pre deti a dorast, Roosveltova 18, 
040 01 Košice,  tel. 0908 630 009, jankakarlova@gmail.com  
6MUDr. Marcela Lancošová, Všeobecná ambulancia pre deti a dorast, Maršala 
Koneva 1, 040 22 Košice,  tel. 0905 572 174, marcelkalancosova@gmail.com  
7MUDr. Zuzana Haviarová, Všeobecná ambulancia pre deti a dorast, 
Malinovského 2A, 977 01 Brezno,  tel. 0907 090 686, 
marcelkovazuzana@gmail.com  
8MUDr. Eva Kasperová, Všeobecná ambulancia pre deti a dorast, Radvanská 
26, 974 01 Banská bystrica,  tel. 0908 548 137, evkasperova@gmail.com  
9MUDr. Zora Zdráhalová, Všeobecná ambulancia pre deti a dorast, Bystrická 
16, 034 01 Ružomberok,  tel. 0907 135 194, zora@zdrahalova.sk  
10MUDr. Beata Drusková, Všeobecná ambulancia pre deti a dorast, Zarevúca 
3A, 034 01 Ružomberok,  tel. 0902 264 446, druskova.beata@gmail.com  
11MUDr. Iveta Kuzmiaková, Všeobecná ambulancia pre deti a dorast, 
Nemocničná 4, 026 01 Dolný Kubín,  tel. 0908 062 082, ivetkag@gmail.com  
12MUDr. Monika Priehodová, Všeobecná ambulancia pre deti a dorast, 
Bebravská 1, 821 07 Bratislava,  tel. 0910 963 818, 
aped.ambulancia@gmail.com  
13MUDr. Eva Dzurilová, Všeobecná ambulancia pre deti a dorast, Nezábudková 
5, 821 01 Bratislava,  tel. 0903 790 720, deti.nezabudka@gmail.com   
14MUDr. Marta Špániková, Všeobecná ambulancia pre deti a dorast, 851 01 
Bratislava,  tel. 0903 202 160, martasp@gmail.com  
15MUDr. Zuzana Nagyová, Všeobecná ambulancia pre deti a dorast,  
Veľkoblahovská 44A, 929 01 Dunajská Streda,  tel. 0905 463 114, 
juvenaliads@gmail.com  

Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) on selected skin dermatoses. 
ECESID study 
ECESID study version 2 
Timeline of the biomedical research 
Pre-screening of patients: march-april 2024 
Date of first patient inclusion: april-may 2024 
Study completion date: 31. 12. 2024 
Patient follow-up duration: 2 weeks, with a total of 2 visits: 
• V0 – initial visit - day of enrolment 
• photodocumentation performed by the patient/legal representative after 7 days of application 
• V1 – control visit - after complete recovery from erythema or maximum 14 days from 
enrolment 
Introduction 
Normalization of the skin barrier defence function can be supported by using products that promote 
the physiological process of keratinization and the immune functions of the skin. In patients with 
problematic skin, the use of alternative and complementary treatments also plays an important role, 
as they can be used as add-on to the standard of care treatment. A significant group among 
complementary medicine products includes preparations containing natural substances with a proven 
complex immunomodulatory effect – biologically active polysaccharides (BAP), such as beta-glucans. 
Biologically active polysaccharides are glucose polymers commonly found in fungi, yeasts, bacteria, 
and cereals. They represent some of the most extensively studied natural immunomodulators with 
pluripotent biological effects (anti-infective, antiviral, immunomodulatory). Imunoglukan® is a 
16MUDr. Alena Kadlíčková, Všeobecná ambulancia pre deti a dorast,  
Starohájska 2, 917 01 Trnava, tel. 0903 763 756, alena.kadlickova@gmail.com  
17MUDr.  Martin Matejka, PhD., Všeobecná ambulancia pre deti a dorast 
MEDMA CARE s.r.o., M. Sch. Trnavského 8, 841 01 Bratislava, 
medmacare@medmacare.sk,  tel.: 0911 499 579    
18MUDr. Karin Valdnerová, Všeobecná ambulancia pre deti a dorast BABY CARE 
s.r.o., Eisnerova 6, 841 07 Bratislava; babycareambulancia@gmail.com,  tel.: 
02 6477 4791 
19MUDr. Simona Gábrišová,  Všeobecná ambulancia pre deti a dorast, Bottova 
21, 036 01 Martin, tel.: +421 948 167 726 
20MUDr. Lenka Šofranková, Všeobecná ambulancia pre deti a dorast  INFANTE, 
s.r.o., Daniela Michaeliho 3932/2 , 036 01 Martin, tel.: +421 434 222 458 
Study Design: 
Multicentre, prospective, open-label study. with a novel cosmetic product. 
Number of Patients: 
cca. 100 patients aged from 3 weeks enrolled by investigators in 20 centres 
Primary Endpoints: 
To evaluate the clinical effect of Imunoglukan P4H® ACUTE! cream paste in 
selected skin dermatoses (diaper dermatitis, perioral dermatitis, neonatal 
pustulosis) on: 
• Clinical assessment of erythema using a 5-point severity scale (Clinician’s 
Erythema Assessment - CEA) 
• Investigator’s Global Assessment (IGA) using a 6-point scale 
Secondary Endpoints: 
To evaluate the tolerability of the cosmetic product Imunoglukan P4H® ACUTE! 
cream paste in selected skin dermatoses (diaper dermatitis, perioral dermatitis, 
neonatal pustulosis) using a 3-point tolerability scale. 

Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) on selected skin dermatoses. 
ECESID study 
ECESID study version 2 
complex of biologically active polysaccharides with a predominant content of beta-1,3/1,6-D-glucan 
pleuran, obtained through a patented isolation technology from Pleurotus ostreatus. 
In topical application, Imunoglukan® activates skin immune cells (Langerhans cells – skin macrophages) 
through Dectin-1 receptors on one hand, and on the other hand, it can also activate skin cells that are 
not part of the immune system (keratinocytes and fibroblasts). 
 
In topical application, Imunoglukan® influences: 
• 
function and viability of Langerhans cells 
• 
proliferation and migration of keratinocytes 
• 
stimulation of collagen production in fibroblasts 
• 
tissue regeneration and remodelling 
• 
rate of wound healing 
• 
production of certain cytokines (e.g., IL-1, IL-8, TNF-α) and enzymes (MMP-9) 
• 
enhancement of antioxidant effects 
• 
slowing of cellular aging 
The effectiveness and safety of Imunoglukan® for various types of skin problems have been confirmed 
by numerous laboratory experiments, clinical observations, and open-label studies. For instance, a 
multicenter open-label study conducted in ten dermatological centers in Slovakia and the Czech 
Republic demonstrated a positive effect on alleviating the symptoms of atopic dermatitis. At the sites 
of cream paste application, there was a significant reduction in the number of flare days, the intensity 
of disease exacerbation, and the sensation of itching. Clinical trials have also confirmed very good 
effects of Imunoglukan® cream paste in the treatment of leg ulcers, herpetic infections, and surgical 
wounds following extensive oncological procedures, as well as in healing crusts after chickenpox in 
pediatric patients. The skin condition of patients with seborrheic dermatitis, rosacea, or acne 
significantly improved after cream paste application, and even an anti-aging effect was observed.  
The results of clinical studies and observations confirmed the complex immunomodulatory and 
regenerative effects of Imunoglukan® with no recorded adverse effects. 
 
Study Design 
It is a multicentre, prospective biomedical research conducted in outpatient healthcare facilities. In 
terms of the nature of the study, it is a biomedical research involving the novel cosmetic product 
Imunoglukan P4H® ACUTE! cream paste. 
Investigators/physicians will enrol a total of 100 patients who meet the inclusion criteria. 
Patients enrolled in the study will apply Imunoglukan P4H® ACUTE! cream paste at least 2–3 times 
daily (or as needed) in an appropriate layer to the affected area for a maximum duration of 2 weeks. 
Ingredients (INCI): Aqua, Zinc Oxide, Neopentyl Glycol Dipelargonate, Cetyl PEG/PPG-10/1 
Dimethicone, Triolein, Magnesium Stearate, Gluconolactone, Polyglyceryl-4 Isostearate, Glycerin, 
Sodium Hyaluronate, Beta-glucan, Zea Mays Starch, Tocopheryl Acetate, C10-18 Triglycerides, Glyceryl 
Dioleate, Polyvinyl Alcohol, Magnesium Sulfate, Sodium Benzoate, Calcium Gluconate. 
 
The effect of the application of Imunoglukan P4H® ACUTE! cream paste on the clinical status of 
erythema in skin disease will be assessed by both the physician and the patient/legal representative 
using a 5-point severity scale (Clinician’s Erythema Assessment – CEA) and through the Investigator’s 
Global Assessment (IGA) on a 6-point scale. The tolerability of the cosmetic product Imunoglukan P4H® 

Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) on selected skin dermatoses. 
ECESID study 
ECESID study version 2 
ACUTE! cream paste in the selected indications will be assessed by the physician using a 3-point 
tolerability scale. 
 
Discussion on the design 
The multicentre, prospective design of the research provides a basis for obtaining clinically, 
scientifically, and statistically significant results with the aim of clarifying the impact of the investigated 
intervention on the primary and secondary objectives. For the clinical evaluation of erythema focused 
on reducing and alleviating the duration of selected skin problems, a 2-week follow-up period is 
justified. In addition to confirming the basic hypothesis, the pilot study should also provide data on the 
tolerability, safety, and potential adverse effects. 
Subjects enrolled in the biomedical research will undergo anamnesis data collection during follow-up 
visits and will continuously complete the relevant questionnaire (Patient Diary). 
Project endpoints: 
Primary endpoints – to evaluate the clinical effect of the cosmetic product Imunoglukan P4H® ACUTE! 
cream paste in patients with selected skin dermatoses (diaper dermatitis, perioral dermatitis, neonatal 
pustulosis) on: 
• 
Clinical assessment of erythema using a 5-point severity scale (Clinician’s Erythema 
Assessment 
• 
Investigator’s Global Assessment (IGA) using a 6-point scale 
Secondary endpoints – to evaluate the tolerability of the cosmetic product Imunoglukan P4H® ACUTE! 
cream paste in patients with selected skin dermatoses using a 3-point tolerability scale. 
Inclusion criteria 
• 
signed informed consent 
• 
age ≥ 3 weeks 
• 
diagnosis (at least one of the following): 
o 
perioral dermatitis 
o 
diaper dermatitis 
o 
neonatal pustulosis 
Non-inclusion criteria 
• 
refusal to provide informed consent 
• 
ongoing application of topical corticosteroids, antihistamines or other immunomodulatory 
products 
• 
ongoing use of oral corticosteroids or antihistamines 
• 
known intolerance to any components of the investigational product 
Exclusion criteria 
• 
application of topical corticosteroids, antihistamines, or other immunomodulatory products 
• 
use of oral corticosteroids or antihistamines 
• 
intolerance to the investigational product 
Patient Instruction 

Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) on selected skin dermatoses. 
ECESID study 
ECESID study version 2 
The attending physician will instruct the patient/legal representative on the elimination of irritating 
factors 
(such 
as 
soaps, 
shampoos, 
bath 
foams, 
perfumed 
wet 
wipes, 
sucking 
on 
hands/fingers/toys/food, etc.) and on refraining from using any other products for the topical 
treatment of the diagnosed skin condition during the course of the study. 
 
 
List of data collected from subjects enrolled in the study 
Basic Identification 
Data 
o Patient´s code 
o Patient´s initials 
o Date of birth 
o Date of the CRF / Visit date  
Medical History and 
Demographic data 
o Age 
o Gender 
o Current comorbidities 
o Current treatment of the comorbidities   
Diagnostic Procedures 
o Clinical assessment of erythema using a 5-point severity scale 
o Investigator’s Global Assessment (IGA) using a 6-point scale 
o Assessment of cosmetic product tolerability using a 3-point scale 
Primary Endpoints 
o Evaluation of the clinical status of erythema after treatment 
o Overall severity and improvementof selected dermatoses by the 
investigator  
Secondary Endpoints 
o Evaluation of product tolerability 
Visit schedule and assessment timeline 
Number of the visit 
V0 
V1 
Time of the visit 
Initial 
examination 
After the disappearance of 
symptoms, or 
after14 days 
Informed consent 
X 
 
Inclusion/Non-inclusion criteria 
X 
 
Exclusion criteria 
X 
 
Demographic data 
X 
 
Medical history 
X 
 
Comorbidities 
X 
 
Dispensing of medication 
X 
 
Clinical assessment of erythema (CEA) 
X 
X 
Investigator’s Global Assessment (IGA) 
 
X 
Assessment of tolerability 
 
X 
Number of papules in selected dermatoses 
X 
X 
Adverse events 
 
X 
Photodocumentation of the affected area 
X  
(physician) 
X  
(physician) 

Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) on selected skin dermatoses. 
ECESID study 
ECESID study version 2 
 
Required diagnostic procedures 
Clinical assessment of erythema (Clinician’s Erythema Assessment – CEA) 
At each visit, the physician will record in the CRF the value based on the Clinical Erythema Assessment 
(CEA) scale using a 5-point scale: 
• 
0 = no erythema 
• 
1 = very mild erythema: light pink 
• 
2 = mild erythema: pink 
• 
3 = moderate erythema: red 
• 
4 = severe erythema: intense red 
Investigator’s Global Assessment (IGA) 
At visits V0 and V1, the physician will record in the CRF the value based on the Investigator’s Global 
Assessment (IGA) using a 6-point scale: 
• 
-1 = worsening 
• 
0 = no response 
• 
1 = mild response: 10–30% improvement 
• 
2 = moderate response: 31–60% improvement 
• 
3 = excellent response: 61–90% improvement 
• 
4 = complete response: 91–100% – clear improvement 
Assessment of cosmetic product tolerability 
At visit V1, the physician will record in the CRF the assessment of tolerability using the following scale: 
• 
0 = poor 
• 
1 = good 
• 
2 = excellent 
Adverse event log 
In the event of adverse events, the physician will complete the log and record the occurrence of 
adverse events in the CRF. 
Patient diary 
Throughout the study, the patient/parent will record selected parameters daily to assess the progress 
of the skin condition. 
Amendments to the Protocol, Other changes in the Conduct of Biomedical Research 
Patient diary (completed continuously by the 
patient/parent) 
X 
X 

Effect of cream paste containing pleuran (β-glucan from Pleurotus ostreatus) on selected skin dermatoses. 
ECESID study 
ECESID study version 2 
Any changes to the protocol will be implemented in the form of a Protocol Amendment. Changes in 
the conduct of the biomedical research are not permitted. 
 
 
Personal Data Protection 
All patients in this project will be identified using a unique ID. Patient identification using this ID will 
not be possible. Source data may only be verified by the monitor. The unique ID of a particular patient 
will be known only to the physician or monitor. Personal identification data included in this project will 
consist of: date of birth, gender, and patient initials. The nature of personal data identifiers complies 
with all relevant legislative requirements.