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CTRI Number  CTRI/2021/02/031309 [Registered on: 16/02/2021] Trial Registered Prospectively
Last Modified On: 08/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [safety and efficacy]  
Study Design  Other 
Public Title of Study   Effect of Moisturizer in Female Subjects with Mild to Moderate Eczema 
Scientific Title of Study   An Open-label, Single Centre Study to Determine the Effect of Test Product in Adult Female Subjects with Mild to Moderate Eczema 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B00704, Ver#02, Dated 29 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  Wipro Manufacturing Services Sdn Bhd 
Address  Wipro Manufacturing Services Sdn. Bhd. No. 7 Persiaran Subang Permai, Taman Perindustrian Subang 47610 Selangor Darul Ehsan, Malaysia. Phone 603 56315588 Fax 603 56311778 
Type of Sponsor  Other [Personal Care Industry] 
 
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= 1  
Name of Committee  Approval Status 
OM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mild to moderate Eczema on flexural surfaces of extremities i.e. Knee fronts, Back of elbows, inner forearm, inner upper arm etc., Hands and Feet or any other part of body  
Patients  (1) ICD-10 Condition: L208||Other atopic dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Facial Moisturizer   Subjects will be instructed to apply pea‐sized amount of test product twice a day for each eczema site on their body to moisturize the test skin site 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Age: 18to 65 years (both inclusive) old healthy, non-pregnant and non-lactating female at the time of consent.
2. Females who have childbearing potential should have a negative urine pregnancy test at the time of screening visit.
3. 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].
4. Subjects with at least two active lesion on feet/face/hands or any part of body.
5. Subjects have only few or no pigmentation on the selected test site.
6. Subject’s in general good health as determined by Investigator based on medical history.
7. Subjects must agree to refrain from shower/bath or generally wet their skin within 3 hours before a schedule study visits.
8. Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits.
9. Subjects must be able to understand and provide written informed consent to participate in the study.
10. Subjects should be willing and able to follow the study protocol to participate in the study.
 
 
ExclusionCriteria 
Details  1. Subjects with chronic or acute skin diseases, except atopic eczema on any part of the body.
2. Subjects with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
3. 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.
4. Subjects who are receiving the following topical or systemic treatments.
5. Subjects with anti-inflammatory and/or anti-histaminesuse for 7 days previous to randomization and throughout the study.
6. Subjects with cough suppressants and/or topical or inhaled corticosteroids.Use for 7 days previous to randomization and throughout the study.
7. Subjects with use of retinoids and/or immunosuppressant’s during the previous 6 months.
8. Subjects have diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
9. Participation in a similar clinical study within the previous 90 days.
10. Any surgical treatment previous three months or planned during the study.
11. Any subject in the Principal investigators opinion not considered suitable for enrollment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Selection of unaffected and affected test sites by the dermatologist using instrument evaluations.
2. Calculation of eczema area by dermatologist using Eczema Area and Severity Index (EASI).
 		 1. On Day 01 before application and on Day 02, Day 07, Day 14 and Day 28 after product usage
2. On Day 01 before application and on Day 02, Day 07, Day 14 and Day 28 after product usage

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Dermatologist Visual Skin Assessment for erythema/redness and dryness.
2. To assess the effect of test product on Global Assessment Scale (IGA).
3. To assess the subjective self-assessment and
4. To assess the subjective perception about product.
 		 1. On Day 01 before application and on Day 02, Day 07, Day 14 and Day 28 after product usage
2. On Day 01 before application and on Day 02, Day 07, Day 14 and Day 28 after product usage
3. On Day 01 before application and on Day 07, Day 14 and Day 28
4. On Day 07, Day 14 and Day 28 after product usage.
 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/02/2021 
Date of Study Completion (India) 16/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="28" 
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  

The objective of this study is to evaluate the efficacy of the moisturizer on eczema symptoms in female subjects with mild to moderate eczema in a 4-week home use test. For the purpose of this study, compatibility means that the test product does not worsen the skin condition, determined by an assessment of the lesional and non-lesional skin.

 
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