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CTRI Number  CTRI/2024/12/078157 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 06/09/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Single Arm Study 
Public Title of Study   Moisturization Activity of Gowriz skincare  
Scientific Title of Study   A Clinical study to Evaluate the 24hrs Moisturization Potential of Gowriz skincare Multiple Lotions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CCFT420 Version 1.0 dated 20 Nov 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Robin Chugh  
Designation  Principal Investigator 
Affiliation  CCFT Laboratories 
Address  1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road

Meerut
UTTAR PRADESH
250002
India 
Phone  7078103723  
Fax    
Email  robinderm25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Puneet Mittal 
Designation  Clinical Research Consultant 
Affiliation  CCFT Laboratories 
Address  1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road

Meerut
UTTAR PRADESH
250002
India 
Phone  8937015757  
Fax    
Email  puneetmittal@mgcts.org  
 
Details of Contact Person
Public Query  
Name  Puneet Mittal 
Designation  Clinical Research Consultant 
Affiliation  CCFT Laboratories 
Address  1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road


UTTAR PRADESH
250002
India 
Phone  8937015757  
Fax    
Email  puneetmittal@mgcts.org  
 
Source of Monetary or Material Support  
CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India, 250002 
Gowriz skincare Pvt Ltd ,296, Riverdale ext dyalpu, Zirakpur, Mohali- 140603, Punjab 
 
Primary Sponsor  
Name  Gowriz skincare Pvt Ltd 
Address  296, Riverdale ext dyalpu, Zirakpur, Mohali- 140603, Punjab 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Robin Chugh  CCFT laboratories  AR multispecialty hospital and research center, 1st Floor room 3, Skin testing lab , CCFT laboratories, Delhi Road
Meerut
UTTAR PRADESH 		 7078103723

robinderm25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ARMHRC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Test Product: 1. M1 50 Grm, 2. M2 50 Grm, 3. M3 50 Grm, 4. M4 50 Grm  Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 24 hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Gender: Male or Female with age 18-45, with male:female (50:50)ratio with normal , oily (avoid acne and too much oily skin)
and combination skin. 3 to 4 candidates with Sensitive skin.
2. Subjects willing to give written informed consent
3. Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
4. Are free of any systemic or dermatologic
disorder, which, in the opinion of the investigator, will interfere with
the study results or increase the risk of adverse events.
5. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study. 
 
ExclusionCriteria 
Details  1. Pregnant or nursing mothers
2.Scars, excessive terminal hair or tattoo on the studied area
3.Henna tattoo anywhere on the body (in case of studies involving
hair dyes)
4.Dermatological infection or pathology on the level of studied area
5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw
material or hair dye)
6.Any clinically significant systemic or cutaneous disease, which may
interfere with study treatment or procedures
7.Chronic illness which may influence the outcome of the study
8.Subjects on any medical treatment either systemic or topical which
may interfere with the performance of the study treatment (presently
or in the past 1 month)
9.Subject in an exclusion period. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in hydration, TEWL   T0min, T+30min, T+3hrs, T+8hrs, T+ 24hours  
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   23/12/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Test Product:
1. M1 50 Grm
2. M2 50 Grm
3. M3 50 Grm
4. M4 50 Grm

Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 24 hour 
 
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