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CTRI Number  CTRI/2022/02/040184 [Registered on: 10/02/2022] Trial Registered Prospectively
Last Modified On: 02/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Other (Specify) [sulfate-free parabiotic cleanser]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical study to determine the safety and a combined effect of the Test products Skidel Bar with TEP-AD Lotion (with/without parabiotics) and Skidel Foam with TEP-AD Lotion (with/without parabiotics) in Healthy Human Subjects with light to medium red and itchy skin (8-Weeks Home Use Test) 
Scientific Title of Study   A Synergy, Safety, Efficacy, Skin Compatibility Study of Skidel Bar, Skidel Foam and TEP-AD Daily Lotion in Healthy Human Subjects with Mild to Moderate Atopic Dermatitis in 8-Weeks Home Use Test. 
Trial Acronym  NB220002 
Secondary IDs if Any  
Secondary ID  Identifier 
NB220002-IH, Version No. 01 (Final), 02 Feb 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Medical Director Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar - 382421

Gandhinagar
GUJARAT
382421
India 
Phone  91-79-48983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Medical Director Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar - 382421


GUJARAT
382421
India 
Phone  91-79-48983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar - 382421

Gandhinagar
GUJARAT
382421
India 
Phone  91-79-48983895  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
NovoBliss Research Private Limited Office A 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar - 382421 
 
Primary Sponsor  
Name  Inzpera Healthsciences Limited 
Address  215-217, Avior Corporate Park, Nirmal Galaxy, LBS Marg. Mulund west, Mumbai - 400080 
Type of Sponsor  Other [Develops, manufactures, and markets pharmaceuticals] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Maheshvari Patel  NovoBliss Research Private Limited  Office A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat - India
Gandhinagar
GUJARAT 		 9909013236

maheshvari@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Subjects with Mild to Moderate Atopic Dermatitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Treatment A) Combination of Skidel Bar and Tep-AD Daily Lotion (with parabiotics)  Skidel Bar: Sulfate-free parabiotic cleanser, the unique blend of ingredients like Avocado Oil and Shea butter Tep-AD Daily Lotion is the first of its kind parabiotic (mildly heat-treated L. Plantarum HEAL19) based topical formulation for dry, irritated, and sensitive skin with a unique blend of Ingredients, like probiotic-mimic active (L.Plantarum HEAL19) and pure ceramide III:cholesterol:100% oat oil in the ratio 3:1:1 Wet the bar, lather and massage gently on the face and over the entire body. Rinse well after use and pat dry. Apply sufficient quantity of lotion in the morning within 30 mins of taking a shower and before going to bed at night time directly on the face, body and affected atopic dermatitis area for continuous 60 Days (8 weeks) 
Intervention  Treatment B) Combination of Skidel Bar and Tep-AD Daily Lotion (without parabiotics)  Skidel Bar: Sulfate-free parabiotic cleanser, the unique blend of ingredients like Avocado Oil and Shea butter Tep-AD Daily Lotion without parabiotic and with pure ceramide III:cholesterol:100% oat oil in the ratio 3:1:1 Wet the bar, lather and massage gently on the face and over the entire body. Rinse well after use and pat dry. Apply sufficient quantity of lotion in the morning within 30 mins of taking a shower and before going to bed at night time directly on the face, body and affected atopic dermatitis area for continuous 60 Days (8 weeks) 
Intervention  Treatment C) Combination of Skidel Foam and Tep-AD Daily Lotion (with parabiotics)  Skidel Foam: Sulfate-free parabiotic cleanser, the unique blend of ingredients like Avocado Oil and Shea butter Tep-AD Daily Lotion is the first of its kind parabiotic (mildly heat-treated L. Plantarum HEAL19) based topical formulation for dry, irritated, and sensitive skin with a unique blend of Ingredients, like probiotic-mimic active (L.Plantarum HEAL19) and pure ceramide III:cholesterol:100% oat oil in the ratio 3:1:1 Shake the Skidel Foam bottle before every use. Open the dust cap and pump out sufficient quantity of Skidel Foam onto subject’s palms. Apply onto the face and over the entire body and scalp. Rinse well after use and pat dry. Skidel Foam can be used a Shampoo. Apply sufficient quantity of lotion in the morning within 30 mins of taking a shower and before going to bed at night time directly on the face, body and affected atopic dermatitis area. Application to be done for continuous 60 Days (8 weeks). 
Intervention  Treatment D) Combination of Skidel Foam and Tep-AD Daily Lotion (without parabiotics)  Skidel Foam: Sulfate-free parabiotic cleanser, the unique blend of ingredients like Avocado Oil and Shea butter Tep-AD Daily Lotion without parabiotic and with pure ceramide III:cholesterol:100% oat oil in the ratio 3:1:1. Shake the Skidel Foam bottle before every use. Open the dust cap and pump out sufficient quantity of Skidel Foam onto subject’s palms. Apply onto the face and over the entire body and scalp. Rinse well after use and pat dry. Skidel Foam can be used a Shampoo. Apply sufficient quantity of lotion in the morning within 30 mins of taking a shower and before going to bed at night time directly on the face, body and affected atopic dermatitis area. Application to be done for continuous 60 Days (8 weeks). 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age: For children: 2 to 17 years (both inclusive) at the time of parental consent/assent and For Adults: 18 to 65 years (both inclusive) at the time of consent.
2) Sex: Healthy children (male or female) and adults (males and non-pregnant/non-lactating females) with mild to moderate atopic dermatitis.
3) Subject’s with mild to moderate atopic dermatitis determined by Eczema Area and
severity Index (EASI) score with moderate erythema (redness: score 2) and mild scratch
mark (scratching: score 1) will be enrolled into the study.
4) Subject is diagnosed with mild to moderate atopic dermatitis with at least 1 active lesion
that is accessible for instrumental measurements.
5) Females of childbearing potential (above 14 years of age to menopause) should have a
a negative urine pregnancy test at the time of screening visit.
6) Subjects (adults and children) are generally in good general health as determined from a
recent medical history, except for atopic dermatitis.
7) If subjects (adults and children) are using or taking any prescription or over the counter
(OTC) medications prescribed by their physicians, they must be taking the medication for
at least 4 weeks.
8) Subject’s and child’s legal parent or guardian must agree to use the same brands and agree not to switch brands or variants of any skincare products during the study period.
9) Subject’s and child’s legal parent or guardian must agree to limit the sun exposure to
affected areas such as arms, legs covered during prolonged sun exposure.
10) Subject’s and child’s legal parent or guardian must agree to dress the subjects in loose
clothing to allow easy exposure to the entire body during study visits and throughout the study duration of 60 days.
11) Subjects and Legal parents or guardian must avoid allowing the subject a hot or cold
beverages within one hour of their scheduled visits and for the duration of all clinic visits,
warm beverages are allowed.
12) Subjects and Legal parents or guardian must avoid allowing subject to swim or play in
chlorinated water during the study period.
13) Subjects are not allowed to participate in any other study until this study is complete.
14) Subjects and child’s legal parent or guardian must be willing and able to follow the study directions and to return for all specified visits with the subject.
15) Subjects and Child’s legal parent or guardian must be willing to stop using all of the
subject’s normal cleansing agents i.e. soap/foams, body cleansing milk and moisturizing
body lotions for the duration of the study (8 weeks) and to use the provided test treatment
Bar/Foam and daily lotion as directed.
16) Subjects and Child’s legal parent or guardian must agree to record each use of the test
product in the subject’s diary card on daily basis.
17) Subjects and Child’s legal parent or guardian must agree to record medication use during the study.
18) Subject’s and child’s legal parent or guardian must read, sign, and receive a copy of
Informed Consent/Parental Informed Consent prior to initiate of study procedures. 
 
ExclusionCriteria 
Details  1) The subject’s or Child’s legal parent or guardian is an employee of the Sponsor or CRO.
2) Change in current prescriptions (within 4 weeks of screening) or new and/or additional
prescriptions for the skin condition (within 4 weeks of screening) or during the study.
3) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or
fragrances.
4) The subject has any other skin conditions i.e. cuts, scratches, ringworms, etc. which in the
opinion of the Investigator, will interfere with the study results or will create undue risk for
the subject.
5) The subject has any of the following conditions or factors that the Investigator believes may
affect the response of the skin or the interpretation of the test results, including, but not
limited to diabetes, hepatic conditions, epilepsy, thyroid or have or had any type of cancer.
6) The subject is currently taking or has taken any medication, which the Investigator believes
may influence the interpretation of the data, such as 3 or more dosages or 3 or more days of
anti-inflammatories (within 1 week of study enrolment) or anti-histamines.
7) The subject must not have participated in a clinical study within 4 weeks prior to the
screening visit of this study.
8) Any other condition which could warrant exclusion from the study, as per the
dermatologist’s/investigator’s discretion.
9) Pregnant or breastfeeding or planning to become pregnant during the study period.
10) History of chronic illness which may influence the cutaneous state. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the synergic effects of test treatment(s) (Skidel Bar and Skidel Foam when its
given with Tep-AD Daily lotion with and without parabiotics) on atopic dermatitis severity on
adult and child subject’s affected skin by using SCORAD Index, Eczema Area and Severity Index
(EASI)  		 Change from baseline i.e. Day 01 before use to Day 30 (±2 days) and Day 60 (±2 days) after product usage by Dermatologist/Dermatologist’s Trained Evaluator 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the synergic effect of test treatment(s) (i.e. Skidel Bar and Skidel Foam when its given with Tep-AD Daily lotion with and without parabiotics) in terms of change in Staphylococcus aureus (S. Aureus) growth using skin swab analysis of lesion areas by conventional culture method - with manual colony counting.  Change from baseline on Day 1 before use Vs. Day 30 (±2
days), Day 60 (±2 days) after use  
To assess the synergic effect of the test treatment(s) [i.e. Skidel Bar and Skidel Foam when its given with Tep-AD Daily lotion with and without parabiotics] in terms of improvement/change in itching using Visual Analogue scale (VAS).  Change from baseline on Day 1 before use Vs. Day 30 (±2 days), Day 60 (±2 days) after use 
To assess the synergeic effect of the test treatment(s) [i.e. Skidel Bar and Skidel Foam when its given with Tep-AD Daily lotion with and without parabiotics] in terms of skin hydration on (lesional and non-lesional sites) using MoistureMeterEpiD  Change from baseline on Day 1 before use to Day 30 (±2 days), Day 60 (±2 days) after use of test product  
To assess the synergeic effect of the test treatment(s) [i.e. Skidel Bar and Skidel Foam when its
given with Tep-AD Daily lotion with and without parabiotics] in terms of improvement in skin
barrier function i.e. Transepidermal water loss (TEWL) on (lesional and non-lesional sites) using Vapometer 		 Change from baseline on Day 1 before use to Day 30 (±2 days), Day 60 (±2 days) after use of test treatment 
To assess adult subject’s/child’s experience on fast relief from rash, provide quick wound heal, moisturization, redness, swelling, itching, urticaria, smooth & gentle on adult’s/child’s skin by Quality of Life (QoL) subjective self-assessment questionnaires for adults & parental/guardian questionnaires in terms of product(s) perception   On Day 30 (±2 Days) and Day 60 (±2 Days) after use of test treatment(s) 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2022 
Date of Study Completion (India) 14/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="25" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a double-blind, four-arm, four treatment, single-centre, synergy, safety and efficacy, a skin compatibility clinical study of ‘Skidel Bar, Skidel Foam and Tep-AD Daily Lotion’ in Healthy Human Subjects with mild to moderate Atopic Dermatitis with at least 1 active lesion at the time of study

enrollment in 8-Weeks Home Use Test. Complete double-blind is not possible considering test treatment Bar and Foam, however, double-blinding will be kept for Daily Lotion with probiotics and without probiotics. A sufficient number (maximum of 64) of male and female adults subjects, children/teenager subjects with a legal parent or legal guardian approval will be recruited to ensure a total of 15 subjects/arm complete the study. Qualifying siblings and family members within the same household are permitted in the study. The Dermatologist’s trained evaluator/physician will determine the subject eligibility and conduct a clinical evaluation of the SCORAD and Eczema Area and Severity Index (EASI) and general skin condition and select at least one (1) lesion site of the subject and final eligibility will be verified by the Dermatologist for subject enrolment. The selected sites (lesion and non-lesion) will be marked on a body map for easy return to the same site at subsequent study visits. The dermatologist’s trained evaluator will also select a single unaffected (non-lesion) site (3 cm * 3 cm), at least 5 centimetres from the nearest affected site, for instrumental hydration assessments. Digital photographs will be taken of the targeted region to confirm the evaluation done by a trained evaluator from the Dermatologist. 

Before entering the facility, at security check-post, the subject and/or the subject’s with legal parent/legal guardian will be asked for a pre-entry inquiry check for COVID-19 exposure and symptoms. The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent and/or assent from the subjects and the subjects legal parent/legal guardian. 

The adult subject and child’s legal parent/legal guardian will be instructed to visit the facility with their child as per the below visits:

• Visit 01: Screening Visit and Enrolment on Day 01

• Visit 02: Treatment Phase Day 30 (Å}2 Days)

• Visit 03: Treatment Phase & End of the Study Day 60 (Å}2 Days)

Adult subjects and Children’s legal parents/legal guardians will be provided with the subject diary to complete every day. In screening visit mild to moderate atopic dermatitis skin will be determined using SCORAD and Eczema Area and Severity Index (EASI) my dermatologist’s trained evaluator/Investigator will be enrolled on the study.

During the study, visual analogue scale (VAS) for improvement in itching, SCORAD, Eczema area and severity Index, skin hydration using MoistureMeterEpid or equivalent instrument, skin barrier function i.e. Transepidermal water loss (TEWL) using Vapometer or equivalent instrument, Skin swab for S. Aureus counting will be performed before and after application at each time points. Skin swab analysis and subjects self-Assessment questionnaire for product perception will be done on days 30 and 60. 

During the 8 week study, subjects and legal parents/guardians are asked to replace the subject’s regular cleaning soap/foam, body lotion with the provided test treatment (Skidel Bar/Foam and body lotion for their moisturization and cleansing needs. Subjects & Parents /guardians will be asked to use the provided cleaning Skidel Bar or Foam and body lotion as they normally would use a body lotion, bar, shampoo, foam on the subjects. 

The test treatment cleaning Skidel Bar/foam and Tep-AD daily lotion, are cleared for a market by Inzpera Health sciences, which are hypoallergenic and have passed a Human Repeated Insult Patch testing (HRIPT) done by Inzpera Health sciences. The expected study duration of this study will be a maximum of 62 days (60 Days trial duration +2 Days of window period) from enrolment.

Subjects and Legal parents/guardians should continue to apply the subject’s medical (prescription and/or over the counter (OTC) treatments if the treatments have been prescribed by a physician. Subjects, Legal parents or guardians may apply normal skincare products on the subject’s face or hands, including sunscreens and medication and use normal hair products, i.e. shampoos, conditioners, detanglers. Subjects, legal parents/guardians are asked not to change brands or variants of these products during the study period.

Evaluations will be conducted at screening i.e. week 0 baseline, week 4 and week 8-time points. The dermatologist’s trained evaluator will provide a consensus score for all attributes needed for the calculation of SCORAD, EASI. Skin conductance and capacitance will be clinically measured at the selected lesional and non-lesional sites taking instrumental readings. Subjects and Children’s legal parents and guardians will be asked to complete a quality of life questionnaire, at home before the baseline visit. These questions about their symptoms and activity limitations and behaviours will be asked to complete a few question questionnaires about their perception of the skin condition of lesions sites (area of atopic dermatitis) selected by the study doctors, these questionnaires will be administered at baseline and during the Day 30 (week 4) and Day 60 (week 8) study visits. Skin swab will be collected from the selected single (1) lesion site to see the change in microbial (S. Aureus) growth from baseline on Day 1 before application of test product to Day 30 and Day 60 counts after test product use.





 
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