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CTRI Number  CTRI/2021/06/034406 [Registered on: 25/06/2021] Trial Registered Prospectively
Last Modified On: 03/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetic]  
Study Design  Other 
Public Title of Study   To evaluate the efficacy of a moisturizing cream in the treatment of Eczema. 
Scientific Title of Study   A real-world study to evaluate the effectiveness of a moisturizing cream as an adjuvant in the treatment of Eczema. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CL/095/0121/STU Version No: 1 of 15th January 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suneel Vartak 
Designation  Dermatologist / Principal Investigator 
Affiliation  Skin Clinic 
Address  Skin Clinic, Flat No. 112, B-Wing, Rajan Complex, Above Annapurna Sweets, Datta Mandir Chowk, Nashik Road

Nashik
MAHARASHTRA
422101
India 
Phone  0253-2466268  
Fax    
Email  suneel.vartak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monil Gala 
Designation  Medical Advisor - Medical Affairs Department 
Affiliation  Dr. Reddy’s Laboratories Ltd. 
Address  7-1-27, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  040-49048400  
Fax    
Email  Monil.yogesh@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Sucheta Pandit 
Designation  Clinical Research Specialist - Medical Affairs Department 
Affiliation  Dr. Reddy’s Laboratories Ltd. 
Address  7-1-27, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  040-49048400  
Fax    
Email  suchetaakshay.p@drreddys.com  
 
Source of Monetary or Material Support  
Dr. Reddys Laboratories Ltd., 7-1-27, Ameerpet Hyderabad 500016, India 
 
Primary Sponsor  
Name  Dr Reddys Laboratories Ltd 
Address  7-1-27, Ameerpet Hyderabad 500016, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suneel Vartak  Skin Clinic  Flat No. 112, B-Wing, Rajan Complex, Above Annapurna Sweets, Datta Mandir Chowk, Nashik Road
Nashik
MAHARASHTRA 		 0253-2466268

suneel.vartak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yash Societys Sujata Birla Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L30||Other and unspecified dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Venusia Max Cream  Sufficient quantity (depends on area of eczema) product to be applied on affected areas by gentle rubbing. Twice a day application for 30 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Voluntary men and women with Atopic Dermatitis, Eruptive Eczema, Chronic Lichenified Eczema, Lichen Simplex Chronicus, Discoid Eczema, Allergic Eczema, with EASI scores 8 -21 or more 
 
ExclusionCriteria 
Details  Pregnant women by UPT, Lactating mothers

Participants with dry skin.

Localised psoriasis patients. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical evaluation

Instrumental evaluation for Skin Hydration and Trans epidermal water loss

Self-Assessment (cutaneous dryness, Itching, Burning)
 		 Day 0, Week 2, Week 4 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="113" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2021 
Date of Study Completion (India) 15/12/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Day 0
  • Explanation of the Study and procedures. 
  • Collection of Informed consent 
  • Selection of volunteers by Inclusion/ exclusion criteria. 
  • Participants will be randomized into 2 groups based on their EASI scores - One group will get prescribed treatment with moisturizing cream and other group will get only prescribed treatment without any moisturizing cream. 
  • Baseline EASI scores 
  • Instrumental readings using MMSC and VapoMeter 
  • Administration of  self-assessment questionnaire to evaluate itching and burning sensation. 
Week 2 and Week 4
    • Same parameters as mentioned above were measured. 
    • Products were retrieved from the participants.
    Conclusion:
    When compared to baseline, Venusia Max Cream used as an adjuvant along with standard
    treatment significantly reduced the EASI score, significantly increased the skin hydration
    measured by MMSC and significantly reduced the trans epidermal water loss measured by
    VapoMeter. It also significantly showed reduction in 5D pruritus and burning sensation in
    self-assessment score.
    Clinical dryness self-assessment score has been done using a binary scale. There was no
    change in dryness perception by the participants in both the groups after the treatment.
    Also, Venusia Max Cream improved the skin hydration significantly on Eczematous skin of
    patients and significantly reduced the 5D Pruritis score compared to the group where
    Venusia Max Cream was not used as an adjuvant along with standard treatment.
     
    Close