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CTRI Number  CTRI/2018/11/016259 [Registered on: 02/11/2018] Trial Registered Prospectively
Last Modified On: 07/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmaceutical]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To evaluate the efficacy of cosmetic products in skin lightening of healthy human volunteers. 
Scientific Title of Study   Efficacy evaluation of cosmetic formulations in conferring skin lightening in healthy human volunteers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/ITSL/2018-02 Version 1.0 Dated 12 Oct 2018   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sapna R 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  First floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  sapna.r@mscr.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sapna R 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  First floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  sapna.r@mscr.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sapna R 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  First floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  sapna.r@mscr.in  
 
Source of Monetary or Material Support  
ITC Life Sciences & Technology Centre Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India 
 
Primary Sponsor  
Name  ITC Life Sciences Technology Centre  
Address  Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India  
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sapna R  MS Clinical Research Pvt. Ltd.  First floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA 
08041125934
08040917253
sapna.r@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Female subjects at least 45 subjects in the age group of 40-48 yrs, 30 subjects in the age group of 49-60 yrs, at least 30 women with post inflammatory hyperpigmentation marks on face. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. SA 135: 123001  About 4-5 drops to be dispensed using the dropper onto the palms and spread over the entire face after having washed face with the provided cleanser for the entire study course. Frequency:Twice Daily 
Intervention  2. SA 791: 123002  About 4-5 drops to be dispensed using the dropper onto the palms and spread over the entire face after having washed face with the provided cleanser for the entire study course. Frequency:Twice Daily 
Intervention  3. SA 357: 123003  About 4-5 drops to be dispensed using the dropper onto the palms and spread over the entire face after having washed face with the provided cleanser for the entire study course. Frequency:Twice Daily 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Subject is willing to give a written informed consent
2.Subject is a healthy adult female in the age range of 25 - 60 years
3.At least 45 subjects in the age group of 40-48 yrs. (Perimenopausal phase) , 30 subjects in the age group of 49-60 yrs. (Menopausal phase).
4.At least 30 subjects having a wrinkle score between 2 and 4 (moderate/ medium wrinkles) as per the photonumeric scale
5.At least 30 women (mothers of 2-8yr old children) with post inflammatory hyperpigmentation marks on face (post acne / estrogen imbalance related marks). Subjects with mild melasma can be taken in the study.
6.Subject who is willing to comply with the study protocol and abide by the study restrictions such as refraining from using cosmetic/ medicinal/ ayurvedic/ 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 product during the entire study course.
7.Subjects willing to visit the centre as per the specified schedule for regular follow up visits.
8.Subjects willing to undergo UPT at the time of screening visit.
 
 
ExclusionCriteria 
Details  1.Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy (as disclosed voluntarily) during the study course.
2.Subject with a known history or present condition of allergic response to any cosmetic products, toiletries or their ingredients including fragrance.
3.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.
4.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.
5.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.
6.Subject with excessive facial hair or scars, which could interfere with evaluation.
7.Subject who shows no skin sensitivity symptoms to the investigational products during the skin sensitivity test.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Dermatological safety, skin lightening and anti- aging efficacy of the investigational products (IP) over baseline and the reference products.  Approximately 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Overall changes in skin conditions on usage of the IP in comparison to baseline and the reference product  Approximately 8 weeks 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/11/2018 
Date of Study Completion (India) 04/02/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Subject Population 
Hundred and Five (105) Indian healthy human adult female subjects will participate in the study:·
At least 30 subjects in the age group of 49-60 yrs (Menopausal phase) ·At least 45 subjects in the age group of 40-48 yrs (Perimenopausal phase)·At least 30 women (mothers of 2-8yr old children) with post inflammatory hyperpigmentation marks on face, representing varied skin types – oily, normal, dry, combination and sensitive skin. 
Each product would be received by at least 35 subjects of which at least 15 women will be from the Pre-Menopausal age group, 10 subjects from the Menopausal group and 10 women with post inflammatory hyperpigmentation marks. 
Determination of sensitivity will be done on the basis of self declaration with information on the stimuli, manifestation and symptoms.In case of not being able to meet the ideal criteria, a variation of ± 2 subjects per skin condition per treatment group is permissible.
Briefing and Procurement of Informed Consent Form 
Study procedure, restrictions and requirements will be explained in detail to the volunteers in the language they understand. All queries from the subjects pertaining to the study will be answered to their satisfaction. Subjects willing to participate in the study will be asked to give their consent by signing the Informed consent form, the contents of which will also be explained to them in detail, in the language they understand. 
Screening 
Subjects providing signature in informed consent form will be screened by the investigator as per the inclusion exclusion criteria, medical history and skin sensitivity test. Only subjects who meet the requirements of this section, will be enrolled in the study. 
Skin sensitivity test: 
About 0.01g of investigational products will be applied at the back of subject’s ear lobes as per randomization on the right and left ears. The product needs to be retained on ear lobes for 24 hours and checked by Dermatologist for symptoms of sensitivity. Only those subjects who show no allergic / irritation symptoms will be enrolled in the study. 
Study restrictions: 
Subjects are required to abstain from using any product (Therapeutic/ Natural/ Synthetic/Cosmetic) other than the provided cleansing solution and investigational products on face and also from undergoing any cosmetic treatments such as facial masks, packs, bleaching, etc. either at home or at parlour during the entire study duration. Subjects are required to visit the evaluation site without any makeup including those for eyes and lips during all evaluation visits. 
Study phase Pre-conditioning 
Subjects will be provided with a mild cleansing solution to use for all cleansing purposes during the study period. Subjects will be asked to wash their face with the provided cleansing solution and rinse completely with water. Face needs to be dried by gentle dabbing of tissue paper. 
Acclimatization 
Subjects will need to get acclimated under controlled temperature and humidity (22oC±5oC and 50%± 30% Relative Humidity) for 15- 30 minutes prior to measurements.
Baseline evaluations 
Evaluation sites·Forehead, Right and Left crow’s feet area for wrinkles/ fine lines ·Right and Left cheeks for skin moisturization and Pores ·Forehead, Right and Left cheeks for skin Color, skin tone and dark spots  Subjects will be evaluated instrumentally and visually for change in skin conditions from baseline. 
Product application 
About 4-5 drops to be dispensed using the dropper onto the palms and spread over the entire face after having washed face with the provided cleanser for the entire study course.Subjects will be requested to maintain a diary to record daily product usage. 
Post treatment assessment   
Subjects will be evaluated instrumentally and visually for change in skin conditions from baseline immediately post first application, and at weeks 2, 4, 6 and 8. 
 
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