lack an outer membrane, the peptidoglycan is exposed and the appropriate endolysin applied externally can perforate the cell wall resulting in osmotically driven lysis and bacterial cell death.26
EndobiomaTM is a recombinant chimeric protein derived from naturally occurring endolysin designed to be highly effective against S. aureus. Its structure combines a cell wall binding domain that specifically recognizes S. aureus peptidoglycan motifs and two enzymatically active domains that lyse them. Low doses of Endobioma have been shown to quickly eliminate S. aureus, including antibiotic resistant strains such as MRSA.27,28 Other typical commensal skin residents, even from the staphylococci genera such as S. epidermidis, are left unaffected.27,29
The aim of this study was to evaluate the efficacy (disease severity and QoL) and tolerance of a cream containing Endobioma applied for two weeks in adults or children with mild-to-moderate atopic dermatitis.
EndobiomaTM is a recombinant chimeric protein derived from naturally occurring endolysin designed to be highly effective against S. aureus. Its structure combines a cell wall binding domain that specifically recognizes S. aureus peptidoglycan motifs and two enzymatically active domains that lyse them. Low doses of Endobioma have been shown to quickly eliminate S. aureus, including antibiotic resistant strains such as MRSA.27,28 Other typical commensal skin residents, even from the staphylococci genera such as S. epidermidis, are left unaffected.27,29
The aim of this study was to evaluate the efficacy (disease severity and QoL) and tolerance of a cream containing Endobioma applied for two weeks in adults or children with mild-to-moderate atopic dermatitis.
MATERIALS AND METHODS
Study Product
The study product contained Endobioma, also known as StaphefektTM SA.100, kindly provided by Micreos Human Health (Bilthoven,The Netherlands) in a 0.0035% simplex cetomacrogol formula.
In vitro Efficacy Against S. aureus
To evaluate the antimicrobial activity of the study product, a small aliquot was inoculated and homogenized with a suspension of S. aureus ATCC 6538 to achieve a final concentration of 106 colony forming unit (CFU) per gram of product. After 30- and 60-minutes contact time at room temperature, the mixture was neutralized to stop enzymatic activity. Serial dilutions were plated on Eugon LT100 agar plates, incubated at 35°C for 48 hours, and surviving S. aureus colonies on the plates counted.
In vivo Study Design
An open-label, interventional, clinical study was conducted in South Africa from September to October 2018, according to the Helsinki Declaration (1964) and its successive updates. Participants replaced their normal cream with the study product and applied it on all body lesions as needed but at least once daily for two weeks. Lipikar Syndet AP+ was provided for daily cleansing.
Participants
Patients were recruited from the IEC (Institut d’Expertise Clinique) database. To be included, male or female Caucasian adults (aged 18 to 70 years) or children (aged 3 months to 12 years) presented an AD diagnosis meeting Hanifin’s criteria (>3 basic features and >3 minor features), with AD present for at least 6 months prior to inclusion (SCORAD >30 at inclusion).
The study product contained Endobioma, also known as StaphefektTM SA.100, kindly provided by Micreos Human Health (Bilthoven,The Netherlands) in a 0.0035% simplex cetomacrogol formula.
In vitro Efficacy Against S. aureus
To evaluate the antimicrobial activity of the study product, a small aliquot was inoculated and homogenized with a suspension of S. aureus ATCC 6538 to achieve a final concentration of 106 colony forming unit (CFU) per gram of product. After 30- and 60-minutes contact time at room temperature, the mixture was neutralized to stop enzymatic activity. Serial dilutions were plated on Eugon LT100 agar plates, incubated at 35°C for 48 hours, and surviving S. aureus colonies on the plates counted.
In vivo Study Design
An open-label, interventional, clinical study was conducted in South Africa from September to October 2018, according to the Helsinki Declaration (1964) and its successive updates. Participants replaced their normal cream with the study product and applied it on all body lesions as needed but at least once daily for two weeks. Lipikar Syndet AP+ was provided for daily cleansing.
Participants
Patients were recruited from the IEC (Institut d’Expertise Clinique) database. To be included, male or female Caucasian adults (aged 18 to 70 years) or children (aged 3 months to 12 years) presented an AD diagnosis meeting Hanifin’s criteria (>3 basic features and >3 minor features), with AD present for at least 6 months prior to inclusion (SCORAD >30 at inclusion).
Measurements
Clinical examinations were performed at baseline, day 7 and day 14. Cutaneous acceptability was assessed by observing physical signs (including erythema, oedema, dryness, desquamation) linked to the study product and questioning about functional signs (including tingling, tightness, and burning sensation) at baseline,day3(byphone),7,and14.Theparticipantsreported their nature, location, intensity, duration, period of appearance after product application. Application number and frequency were also reported.
On days 0, 7 and 14, disease severity was clinically evaluated using SCORAD (SCORing Atopic Dermatitis), and local SCORAD at defined areas. Standardized pictures of the AD lesion were taken on days 0, 3 (by the subject), 7, and 14, focusing on the lesion used for Local SCORAD. Participants completed Patient- Oriented SCORAD (PO-SCORAD) and ranked pruritus, tingling, and burning sensation on a scale from 0 (absent) to 3 (severe) on day 0, 3, 7, and 14. QoL was measured using DLQI (Dermatology Life Quality Index) and CDLQI (Children’s Dermatology Life Quality Index) questionnaires on days 0, 3, 7, and 14.
Data Analysis
Mean and standard deviation were calculated for individual data at each time point and compared to baseline values. Significance thresholds were P<0.05 and P<0.01 for Shapiro- Wilk test. Distribution normality was checked with Shapiro-Wilk test, if distribution was normal, paired Student t-test was applied, and if not, the Wilcoxon test was used. Any statistically significant changes were reported with their corresponding variation from the individual percentage mean. Percentage of patients with improvement was calculated.
Clinical examinations were performed at baseline, day 7 and day 14. Cutaneous acceptability was assessed by observing physical signs (including erythema, oedema, dryness, desquamation) linked to the study product and questioning about functional signs (including tingling, tightness, and burning sensation) at baseline,day3(byphone),7,and14.Theparticipantsreported their nature, location, intensity, duration, period of appearance after product application. Application number and frequency were also reported.
On days 0, 7 and 14, disease severity was clinically evaluated using SCORAD (SCORing Atopic Dermatitis), and local SCORAD at defined areas. Standardized pictures of the AD lesion were taken on days 0, 3 (by the subject), 7, and 14, focusing on the lesion used for Local SCORAD. Participants completed Patient- Oriented SCORAD (PO-SCORAD) and ranked pruritus, tingling, and burning sensation on a scale from 0 (absent) to 3 (severe) on day 0, 3, 7, and 14. QoL was measured using DLQI (Dermatology Life Quality Index) and CDLQI (Children’s Dermatology Life Quality Index) questionnaires on days 0, 3, 7, and 14.
Data Analysis
Mean and standard deviation were calculated for individual data at each time point and compared to baseline values. Significance thresholds were P<0.05 and P<0.01 for Shapiro- Wilk test. Distribution normality was checked with Shapiro-Wilk test, if distribution was normal, paired Student t-test was applied, and if not, the Wilcoxon test was used. Any statistically significant changes were reported with their corresponding variation from the individual percentage mean. Percentage of patients with improvement was calculated.
RESULTS
In vitro results showed that 1g of Endobioma formula rapidly inactivated 106 CFU of S. aureus. Within 30 minutes, 99.99 % of the bacteria were killed and the limit of detection was achieved after one hour. (Figure 1 >4-log CFU reduction)
