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CTRI Number  CTRI/2024/09/073414 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [cosmeceutical/adjuvant therapy]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical study to check the effect of a cream and lotion when used with standard treatment of Atopic Dermatitis i.e., condition that makes the skin itchy and dry. 
Scientific Title of Study   A prospective, interventional, randomized, open label, comparative, three arm, parallel allocation, single centre clinical study to evaluate the effectiveness of Test Products (Cream and Lotion) as an adjuvant in the treatment of Atopic Dermatitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C3B04716; DRL-IND-GGI-064-VENU/2024; Ver:01, Dated:09Aug24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhagirath Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054

Ahmadabad
GUJARAT
380054
India 
Phone  9825618138  
Fax    
Email  bpatel3@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sagar Katare 
Designation  Medical Cluster Head- CR 
Affiliation  Dr. Reddy’s Laboratories Limited 
Address  Dr. Reddy’s Laboratories Limited 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana- 500034

Hyderabad
TELANGANA
500034
India 
Phone  9223772427  
Fax    
Email  sagarkatare@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Sagar Katare 
Designation  Medical Cluster Head- CR 
Affiliation  Dr. Reddy’s Laboratories Limited 
Address  Dr. Reddy’s Laboratories Limited 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana- 500034


TELANGANA
500034
India 
Phone  9223772427  
Fax    
Email  sagarkatare@drreddys.com  
 
Source of Monetary or Material Support  
Dr Reddy’s Laboratories Ltd., 7-1-27, Ameerpet, Hyderabad, Telangana – 500016, India 
 
Primary Sponsor  
Name  Dr. Reddys Laboratories Ltd. 
Address  7-1-27, Ameerpet, Hyderabad, Telangana - 500016  
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Bhagirath Patel  Cliantha Research  Consumer Research Department, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad, Gujarat -380054
Ahmadabad
GUJARAT 		 9825618138

bpatel3@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 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  SoC  SoC will be applied on each affected areas of skin. SoC will be used twice daily (morning & evening). 
Intervention  SoC + Cream  SoC will be applied on each affected areas of skin followed by application of test product. Both SoC and test product will be used twice daily (morning & evening) for 28 days. 
Intervention  SoC + Lotion  SoC will be applied on each affected areas of skin followed by application of test product. Both SoC and test product will be used twice daily (morning & evening) for 28 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Male OR non-pregnant and non-lactating female subjects with age of 18-55 years (both inclusive at the time of consent).
2) Subjects diagnosed with atopic dermatitis based on Atopic Dermatitis Severity Index (ADSI) score between 2 - 8 (Mild to Moderate Eczema).
3) Subjects with two independent lesions.
4) Subject must be willing and able to apply the test product as directed, comply with study instructions and commit to all subsequent visits for the duration of the study.
5) Subjects having good general health and free of any disease state or physical condition that might impair evaluation which in the Investigators opinion, exposes the participant to an unacceptable risk by study participation.
6) Female subjects of childbearing potential must have a negative urine pregnancy test performed at screening visit.
7) Subjects willing to follow all the acceptable forms of contraception as applicable.
8) Subjects who are willing to participate in the study and give voluntary written informed consent.
9) Subjects who are willing and able to follow the study protocol to participate in the study.
10) Subjects willing to not participate in any other clinical study during participation in the current study.
 
 
ExclusionCriteria 
Details  1) Female subjects who are pregnant or breastfeeding or planning pregnancy during the study period.
2) Subjects with dry skin and chronic illness.
3) Subjects with psoriasis (psoriatic lesions).
4) Subjects with any clinically significant systemic disease.
5) Subjects having known allergy to active ingredient OR raw material of the test product.
6) Presence of any cutaneous condition on test site that could interfere with study.
7) Subject who has used an Investigational product in any form or participated in any clinical trial within 30 days prior to first application.
8) Any other condition which could warrant exclusion from the study, as per the investigators discretion.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of test product on eczema by Dermatologist.  Day 01, Day 14 and Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of test product on Skin Moisturization  Day 01 and Day 02 
To assess the effect of test product on skin barrier function by measuring Transepidermal Water Loss (TEWL)  Day 01 and Day 02 
Subject Satisfaction Questionnaire  Day 02, Day 14 and Day 28 
Product Response Index (Perception about Product)  Day 28 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2024 
Date of Study Completion (India) 21/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a prospective, interventional, randomized, open label, comparative, three arm, parallel allocation, single centre clinical study to evaluate the effectiveness of Test Products (Cream and Lotion) as an adjuvant in the treatment of Atopic Dermatitis.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo dermatological and instrumental assessment. Subjective feedback will also be taken regarding the perception of the product and subjects satisfaction after product usage. Safety will be assessed throughout the study by monitoring adverse events.
 
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