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CTRI Number  CTRI/2021/02/031511 [Registered on: 23/02/2021] Trial Registered Prospectively
Last Modified On: 08/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [safety and efficacy]  
Study Design  Other 
Public Title of Study   Safety and efficacy study of cream in subjects with mild to moderate Eczema 
Scientific Title of Study   An Open-Label, Single-Arm Study to Evaluate Efficacy and Safety of Test Product i.e. All Purpose Cream in Mixed Population with Mild To Moderate Eczema 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B00042 Version: 01, Dated 30 Jan 21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549


GUJARAT
380054
India 
Phone  9909013286  
Fax  07966219549  
Email  nkpatel@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Ms Maheshvari Patel 
Designation  Associate Director Consumer Research 
Affiliation  Cliantha Research  
Address  Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549

Ahmadabad
GUJARAT
380054
India 
Phone  9909013236  
Fax  07966219549  
Email  mnpatel@cliantha.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Zydus Wellness Limited  
Address  Zydus Wellness Limited House No. 6 and 7,Sigma Commerce Zone, Near Iskcon Temple, Sarkhej - Gandhinagar Highway, Ahmedabad 380015, Gujarat, India Tel 91 79 67775888  
Type of Sponsor  Other [FMCG] 
 
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 
Dr Nayan Patel  Cliantha Research   Consumer Research Department Garden View Corporate House No 7 Opp Auda Garden Bodakdev Ahmedabad 380054 India Phone 91 79 68221100 Fax 91 79 66219549
Ahmadabad
GUJARAT 		 9909013286
07966219549
nkpatel@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACEAS - IEC  Approved 
ACEAS - IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects with mild to moderate Eczema  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  All Purpose Cream  Subject will be instructed to apply 1.5 g to 2.5 g (a coin size) of test product (as per requirement) twice a day (morning and evening) directly on the face, body and affected eczema area from Day 01 to Day 14 (02 weeks) and document the same to the daily diary. Compliance to dosing will be monitored by study personnel at the clinical facility 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age: 0 Months to 60 years old (both inclusive) at the time of consent/assent.
2. Gender: Male or females
3. Females who have child bearing potential should have negative urine pregnancy test at the time of screening visit.
4. Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects and subject’s Parent/legal guardian/caregiver.
5. APGAR score >7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0-7 days [Refer Appendix VII for APGAR scoring].
6. Subjects [0 months to 17 years] with mild to moderate eczema determined by Three-Item Severity (TIS) score on screening visit will be enrolled into the study.
7. Subjects [18 to 60 years] with mild to moderate eczema determined by Eczema Area and Severity Index (EASI) score on screening visit. [Subjects with moderate erythema (Redness: score 2) and mild scratch mark (Scratching: score 1) will be enrolled into the study].
8. Written informed consent from the Parent/legal guardian/caregiver and verbal/oral assent from children between 7 to 12 years of age in the presence of their parent/legal guardian/caregiver.
9. Written informed consent from the Parent/legal guardian/caregiver and written assent from children between 12 to 18 years of age.
10. Subject’s participating patent/legal guardian/caregiver must be able to provide government authorized legal proof of child’s to participate in the study.
11. Subjects must agree to refrain themselves from shower/bath or generally wet their skin within 3 hours before a schedule study visits.
12. Subjects must use test product on your skin to reduce dryness, especially after a bath when their skin is still moist.
13. Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits.
14. Subjects ensure and confirm that they will be refrained from changing any other products whose use may have an effect on their skin condition during the trial, i.e., laundry detergents, fabric softeners, and products used for bathing.
15. Subjects preferably willing to abide by and comply with the study protocol.
16. Adult subjects should not participate in any other clinical study during participation in the current study.
 
 
ExclusionCriteria 
Details  1. Pregnant female subjects or females planning to get pregnant during study duration.
2. Subjects and subject’s participating parent/ legal guardian/caregiver not willing to stop the use of other body milk /lotion / cream or any other face/body moisturizing product during the study period.
3. Subjects with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
4. Subjects with Chronic illness which may influence the cutaneous state.
5. Subjects with any systemic illness that would impact on the subject’s safety or wellbeing and/or affect the response of the skin or the interpretation of the test results at screening.
6. Subjects participating in a similar clinical study, currently or during the previous 90 days.
7. Subjects in the Investigators opinion not considered suitable for enrollment.
8. Subjects with known history or present condition of allergic response to any other concern that may require medical attention.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To assess effect of test product on adult subject’s affected skin by using Eczema Area and Severity Index (EASI).
2. To assess effect of test product on baby’s affected skin by using Three-Item Severity (TIS).
3. To assess effect of test product on skin in terms of mildness, gentleness, non-irritability, skin erythema/ redness, dryness, itching, rashes, oedema, pruritus, urticaria
4. subjective self-assessment questionnaire
 		 1. Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days).
2. Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
3. Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
4. Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess effect of test product on adult subject’s/baby’s affected skin for erythema using Mexameter®MX 18
2. To evaluate the effect of test product on adult subject’s/baby’s affected skin pH using Skin pH meter
 		 1. Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
2. Day 01 before application to Day 14 (±2 Days)
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/02/2021 
Date of Study Completion (India) 27/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is proposed to evaluate and establish the benefits of the test product on mildness, gentleness and non-irritability on adult and baby skin and soothes the skin, also determine the experience faster relief from pain of and keeps the skin moisturized, upon application relieving dryness, redness, oedema, urticarial and any other reactions. The proposed benefits are evaluated by the pediatrics, subjective assessment questionnaire and instrumental evaluation at Day 1, Day 2, Day 7 and Day 14.

 
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