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CTRI Number  CTRI/2022/09/045434 [Registered on: 12/09/2022] Trial Registered Prospectively
Last Modified On: 08/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceutical]  
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the Effectiveness of a Moisturizer on Skin Moisturization. 
Scientific Title of Study   An Open Label, Single-Arm, Clinical Study to evaluate the Effectiveness of a Moisturizer on Skin Moisturization in adult subjects with mild to moderate acne. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
C3B02408;DRL-IND-GGI-029-ACNE/2022;Version:01,Date17 Aug 22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parth Joshi 
Designation  Principal Investigator 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  8000085049  
Fax  917966219549  
Email  pjoshi@ofacto.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monil Yogesh Gala  
Designation  Medical Advisor 
Affiliation  Dr Reddy’s Laboratories Ltd 
Address  Dr Reddy’s Laboratories Ltd Medical Affairs Department, Dr Reddy’s Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad TELANGANA 500016 India

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax    
Email  Monil.yogesh@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddy’s Laboratories Ltd 
Address  Dr Reddy’s Laboratories Ltd Medical Affairs Department, Dr Reddy’s Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad TELANGANA 500016 India

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax    
Email  Rahul.Rathod@drreddys.com  
 
Source of Monetary or Material Support  
Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India 
Dr Reddy’s Laboratories Ltd Medical Affairs Department, Dr Reddy’s Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad 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 
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 Parth Joshi  Cliantha Research   Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT 		 8000085049
917966219549
pjoshi@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult subjects of both sex (preferably with equal numbers) with age between 18 and 35 years (both inclusive at the time of consent) having acne-prone skin and with mild to moderate acne. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Moisturizer  Subjects will be instructed to apply approximately 2 gm of test product on the entire face. The product will be spread evenly in a circular motion and the product will be allowed to get absorbed in the skin. Product will be used twice daily (morning & evening). 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Age: 18 to 35 years (both inclusive) at the time of consent.
2. Sex: Adult male and non-pregnant/non-lactating female.
3. Subjects with acne-prone skin and with mild to moderate acne condition as per IGA scale for Acne severity.
4. Subjects with oily skin having Sebumeter measurement > 180 (µg/cm2).
5. Subjects with acne marks/spots and visible pores.
 
 
ExclusionCriteria 
Details  1. Subjects with drug induced acne as disclosed by subjects.
2. Subjects undergoing treatment for skin lightening.
3. Subjects who are receiving topical or systemic treatments.
4. Subjects with any pigmentary disorder including freckles and melasma.
5. Subjects using other marketed skin lightening products during the study period or in the past 6 weeks. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of test product in improving the skin moisturization using Corneometer® CM 825 / MoistureMeterSC   Day 01 (before application) and Day 15 (plus minus 2 days) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of test product in improving the skin moisturization using Corneometer® CM 825 / MoistureMeterSC  Day 01 (before application), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
To evaluate the effectiveness of test product in preventing the appearance of new acne by using Investigator’s Global Assessment (IGA) Scale for Acne Vulgaris  Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
To evaluate the effectiveness of test product on acne reduction by using Investigator’s Global Assessment (IGA) Scale for Acne Vulgaris   Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
To evaluate the effectiveness of test product in reducing skin redness using 5-point scale by Dermatologist   Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
To evaluate the effectiveness of test product in Restoring/ Improving the skin barrier function by measuring Transepidermal Water Loss (TEWL) using TEWAmeter® TM300 / Vapometer   Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
To evaluate the effectiveness of test product on reduction of skin sebum level using Sebumeter® SM 815   Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
To evaluate the effectiveness of test product on acne using 3D analysis system   Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
To assess the Subject Satisfaction Questionnaire after product usage   Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days)  
To evaluate Subject Response Index (Perception about Product) after product usage   Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
Exploratory Endpoints:
10.1 To evaluate the effectiveness of test product in reducing skin pigment using 9-point scale by Dermatologist.

10.2 To evaluate the effectiveness of test product in reducing the facial pores using Severity Scoring Scale of Individual Skin Appearance Parameters by Dermatologist.

10.3 To evaluate the effectiveness of test product on reduction / lightening of blemishes using Mexameter® MX 18.

10.4 To evaluate the effectiveness of test product on blemishes and pores using 3D analysis system.  		 Day 01 (before application), Day 15 (plus minus 2 days), Day 30 (plus minus 2 days), Day 45 (plus minus 2 days) and Day 60 (plus minus 2 days) 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2022 
Date of Study Completion (India) 13/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is an open label, single-arm, clinical study to evaluate the effecttiveness of a Moisturizer on skin moisturization in adult subjects with mild to moderate acne.

The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.

There are total 6 visits in the study i.e.,

Visit 01: Screening Visit (Within 30 Days Prior to Day 1)

Visit 02: Enrollment (Day 01)

Visit 03: Evaluation Phase (Day 15 ± 02 Days)

Visit 04: Evaluation Phase (Day 30 ± 02 Days)

Visit 05: Evaluation Phase (Day 45 ± 02 Days)

Visit 06: Evaluation Phase and End of Study (Day 60 ± 02 Days)

 
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