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CTRI Number  CTRI/2023/10/059282 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceutical]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate the safety and efficacy of a test product in female subjects with varied skin type. 
Scientific Title of Study   A double-blind, randomized, single centre, two-arm, placebo-controlled, comparative clinical study to evaluate the safety, in-use tolerability and efficacy of Moisturizing Cream in female subjects with varied skin type. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C3B03546; Ver: 01, Dated 11 Oct 23  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, Block 17-20, Sigma I Corporates, Opp. Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad – 380054

Ahmadabad
GUJARAT
380054
India 
Phone  9825618138  
Fax    
Email  bhagirathrpatel1818@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parth Joshi 
Designation  Overall Trial Coordinator 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Block 17-20, Sigma I Corporates, Opp. Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad – 380054

Ahmadabad
GUJARAT
380054
India 
Phone  8000085049  
Fax    
Email  pjoshi@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Sethi 
Designation  Director Consumer Research 
Affiliation  Cliantha Research 
Address  Consumer Research Department, Block 17-20, Sigma I Corporates, Opp. Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad – 380054

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax    
Email  ssethi@cliantha.com  
 
Source of Monetary or Material Support  
Cliantha Research, Consumer Research Department, Block 17-20, Sigma I Corporates, Opp. Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad – 380054 
DPKA Universal Consumer Ventures Private Limited 3002, 30th Floor, Beau Monde, Tower B, Prabhadevi Road, Prabhadevi, Mumbai - 400025 
 
Primary Sponsor  
Name  DPKA Universal Consumer Ventures Private Limited 
Address  3002, 30th Floor, Beau Monde, Tower B, Prabhadevi Road, Prabhadevi, Mumbai - 400025 
Type of Sponsor  Other [Health and Hygiene] 
 
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 Bhagirath Patel  Cliantha Research  Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054
Ahmadabad
GUJARAT 		 07966135601

bhagirathrpatel1818@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy non-pregnant and non-lactating females between age group of 21 to 50 years (both inclusive at the time of consent) with varied skin type  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Moisturizing Cream  Standard quantity of test product to be applied on cleansed face (using provided face cleanser) using fingertips. Daily application twice a day (morning and evening) from Day 01 till the end of the treatment phase.  
Comparator Agent  Placebo  Standard quantity of test product to be applied on cleansed face (using provided face cleanser) using fingertips. Daily application twice a day (morning and evening) from Day 01 till the end of the treatment phase. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1) Subjects with dry / normal / oily / sensitive skin.
o Subjects with self-perceived normal skin.
o Subjects with dry (readings between 30 – 40) as assessed by MoistureMeterSC.
o Subjects with oily skin having Sebumeter measurement > 150 (μg/cm2).
o Subjects with sensitive skin based on Dr. Baumann’s skin type questionnaire.
2) Subjects having good general health as determined by the Investigator on the basis of medical history.
3) Females of Childbearing potential must have a negative urine pregnancy test performed during Visit 01. 
 
ExclusionCriteria 
Details  1) Subjects undergoing treatment for skin lightening or subjects using other marketed skin lightening products during the study period or in the past 6 weeks.
2) Subjects who are receiving topical or systemic treatments.
3) Subjects receiving medications (e.g., steroids or antihistamines) would compromise the study.
4) Chronic illness which may influence the cutaneous state.
5) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of effectiveness of skin moisturization using MoistureMeterSC   Day 01 (Before application, 30 mins, 2 hours, 4 hours post application), Day 08, Day 15, Day 29, Day 31 
 
Secondary Outcome  
Outcome  TimePoints 
Dermatological assessment of skin dryness using 5-point grading scale   Day 01, Day 08, Day 15, Day 29, Day 31 
Dermatological assessment of skin radiance using Modified Griffiths Scale  Day 01, Day 08, Day 15, Day 29, Day 31 
Dermatological assessment of skin roughness using 5-point grading scale  Day 01, Day 08, Day 15, Day 29, Day 31 
Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using Vapometer   Day 01 (Before application, 30 mins, 2 hours, 4 hours post application), Day 08, Day 15, Day 29, Day 31 
Assessment of skin brightness using Chromameter  Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31 
Assessment of skin elasticity and firmness using Cutometer   Day 01 (Before application, 4 hours post application), Day 08, Day 15, Day 29, Day 31 
Assessment of skin roughness using 3D Analysis System   Day 01 (Before application, 30 mins post application), Day 08, Day 15, Day 29, Day 31  
Assessment of Subject Satisfaction Questionnaire   Day 01 (30 mins, 4 hours post application), Day 08, Day 15, Day 29, Day 31  
Assessment of Product Response Index (Perception about Product)   Day 01 (30 mins post application) 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/11/2023 
Date of Study Completion (India) 01/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="1" 
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  
This is a double-blind, randomized, single centre, two-arm, placebo-controlled, comparative clinical study to evaluate the safety, in-use tolerability and efficacy of a Moisturizing Cream in subjects with varied skin type.

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 clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
 
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