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CTRI Number  CTRI/2017/01/007731 [Registered on: 20/01/2017] Trial Registered Retrospectively
Last Modified On: 06/03/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Anti Aging , Cosmetics]  
Study Design  Other 
Public Title of Study   Anti skin aging efficacy study 
Scientific Title of Study   Efficacy evaluation of cosmetic formulations in conferring anti-skin aging benefits in healthy human volunteers  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SRC/CD/450, Version: 01, Dated: July 21, 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uma Ayachit  
Designation  Scientist 
Affiliation  The KET’s, Scientific Research Centre  
Address  The KET’s, “Scientific Research Centre”,Cosmetology Division, 4th floor, V. G. Vaze college campus,Mithagar Road, Mulund (E), Mumbai- 400 081, India. MAHARASHTRA 400081 India

Mumbai
MAHARASHTRA
400081
India 
Phone  25639644  
Fax    
Email  uma@kelkarcosmetology.com  
 
Details of Contact Person
Scientific Query  
Name  Uma Ayachit  
Designation  Scientist 
Affiliation   
Address  The KET’s, “Scientific Research Centre”,Cosmetology Division, 4th floor, V. G. Vaze college campus,Mithagar Road, Mulund (E), Mumbai- 400 081, India. MAHARASHTRA 400081 India


MAHARASHTRA
400081
India 
Phone  25639644  
Fax    
Email  uma@kelkarcosmetology.com  
 
Details of Contact Person
Public Query  
Name  Uma Ayachit  
Designation  Scientist 
Affiliation   
Address  The KET’s, “Scientific Research Centre”,Cosmetology Division, 4th floor, V. G. Vaze college campus,Mithagar Road, Mulund (E), Mumbai- 400 081, India. MAHARASHTRA 400081 India


MAHARASHTRA
400081
India 
Phone  25639644  
Fax    
Email  uma@kelkarcosmetology.com  
 
Source of Monetary or Material Support  
ITC Life Science and Technology Centre, Peenya Industrial Area, I Phase, Peenya Bangalore- 560058 Karnataka, India  
 
Primary Sponsor  
Name  ITC Life Science and Technology Centre 
Address  Peenya Industrial Area, I Phase, Peenya Bangalore- 560058 Karnataka, India  
Type of Sponsor  Other [Indian Multinational] 
 
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 
Ms Uma Ayachit  The KET’s, “Scientific Research Centre”, Cosmetology Division,   Cosmetology Division, 4th floor, V. G. Vaze college campus, Mithagar Road, Mulund (E), Mumbai- 400 081, India Mumbai (Suburban) MAHARASHTRA
Mumbai
MAHARASHTRA 		 25639644

uma@kelkarcosmetology.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Scientific & Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Wrinkles and dark spots 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Baseline readings   Baseline (week 0) 
Intervention  S  Baseline (week 0), week 2, Week 4, Week 6 , Week 8 , Week 10 , Week 12 assessment of dermatologist, instrument and subject, Approximately, 0.2 to 0.5 g of the provided investigational product to be applied on face, twice daily (post morning bath and 2 hours prior to bed time after having washed face with the provide cleanser) for the entire study course.  
Intervention  T  Baseline (week 0), week 2, Week 4, Week 6 , Week 8 , Week 10 , Week 12 assessment of dermatologist, instrument and subject, Approximately, 0.2 to 0.5 g of the provided investigational product to be applied on face, twice daily (post morning bath and 2 hours prior to bed time after having washed face with the provide cleanser) for the entire study course.  
Intervention  U  Baseline (week 0), week 2, Week 4, Week 6 , Week 8 , Week 10 , Week 12 assessment of dermatologist, instrument and subject, Approximately, 0.2 to 0.5 g of the provided investigational product to be applied on face, twice daily (post morning bath and 2 hours prior to bed time after having washed face with the provide cleanser) for the entire study course.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Subject is willing to give a written informed consent
•Subject is a healthy adult (male or female) in the age range of 35- 60 years
•Subject has a wrinkle score between 2 and 4 (moderate/ medium wrinkles) as per the photonumeric scale
•Subject has at least 2 dark spots on face that are age spots /lentigines marks other than Mealsma or Chloasma
•In case of having used fairness product in the near past Subject is willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face.
•Subject who is willing to comply with the study protocol and abide by the study restrictions such as refraining from using cosmetic or medicinal or ayurvedic or natural products on face and also willing to abstain from undergoing any facial treatments such as facial masks, packs, waxing, threading etc either at home or at parlour other than the provided cream during the entire study course and visiting the centre for regular follow up visits.
•Female subjects of reproductive age group willing to undergo UPT at time of screening visit.  
 
ExclusionCriteria 
Details  •Female subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
•Subject with a known history or present condition of allergic response to any cosmetic products, toiletries or their ingredients including fragrance.
•Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results
•Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti-acne medication) within past 4 weeks or any topical facial medication within 2 weeks before the start of the study, which could compromise the study.
•Subject has not participated in a similar clinical investigation in the past three months or applied skin lightening product on face or undergone a treatment like facial packs, bleaching in the past two weeks.
•Subject with excessive facial hair or scars, which could interfere with evaluation.
•Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety and efficacy of the investigational products (IP) in reducing the facial wrinkles and fine lines in comparison to the baseline and a reference product   Week 0, week 2, week 4, week 6, week 8, week 10 & week 12 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety of long term use of anti-skin aging formulations on all skin types.
To evaluate the overall changes in skin condition upon usage of the IP in comparison to baseline and a reference product  		 Week 0, week 2, week 4, week 6, week 8, week 10 & week 12 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/08/2015 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Double blind, randomized, comparative, parallel design, single centre trial. Total 120 healthy human adult male and female subjects in 1:3 ratio. 35+5 subjects in each of the 3 treatment groups with 10 men and 30 women in each group. Subjects will be assigned the investigational product to use on whole face twice daily. This will be an 12 weeks study. All the subjects will be assessed on Baseline (week 0), week 2, week 4, week 6, week 8, week 10 and week 12.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 Double blind, randomized, comparative, parallel design, single centre trial. Total 120 healthy human adult male and female subjects in 1:3 ratio. 35+5 subjects in each of the 3 treatment groups with 10 men and 30 women in each group. Subjects will be assigned the investigational product to use on whole face twice daily. This will be an 12 weeks study. All the subjects will be assessed on Baseline (week 0), week 2, week 4, week 6, week 8, week 10 and week 12.  
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