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CTRI Number  CTRI/2018/03/012308 [Registered on: 05/03/2018] Trial Registered Retrospectively
Last Modified On: 22/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmaceutical]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the effectiveness of hair tonic for hair fall reduction in healthy human subjects  
Scientific Title of Study   A single blinded (Investigator blinded), randomized study to evaluate and compare the efficacy of the hair leave-on product with a comparator product for scalp hair growth and density 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/ITHS/2016-04, Version 1.0 dated 13 Jun 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sapna R 
Designation  Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, dermatological evaluation room,327/15, first main road, Cambridge layout, Ulsoor, Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax  08041125934  
Email  sapna.r@mscr.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sapna R 
Designation  Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, dermatological evaluation room, 327/15, first main road, Cambridge layout, Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax  08041125934  
Email  sapna.r@mscr.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sapna R 
Designation  Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, dermatological evaluation room, 327/15, first main road, Cambridge layout, Bangalore

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax  08041125934  
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 
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 Sapna R  MS Clinical Research Pvt Ltd  MS Clinical Research Pvt Ltd, 327/15, 1 st main road, Cambridge layout, Ulsoor, Bangalore
Bangalore
KARNATAKA 
08040917253
08041125934
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  Healthy Male and female subjects with complain of hair fall 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Benchmark Product  1 ml of 2% formulation will be given to the female subjects and 1 ml of 5% formulation will be given to the male subjects to use once per day. 
Intervention  Hair Tonic   The investigational product will be given to the male and female subjects to use daily once at night. Frequency- once per day at night Duration: 6 months 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)Subjects to be 21 to 55 year old male and female generally in good health.
2)Female subjects falling under grade 2, 3 and grade 4 of hair loss severity grade evaluated as per standard Photo numeric 6 point scale.
3)Male subjects falling under grade 2, 3 and grade 4 of hair loss severity grade evaluated as per Norwood scale.
4)Subject having hair density 100-200 /cm2 will be included in the study.
5)Hair falls by comb test to be more than 15 hairs.
6)Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
7)Willing to maintain the same hairstyle, hair length and hair color throughout the study.
8)Willingness to have a dot tattoo placed in the target area of the scalp during the study.
9)Willingness to maintain the habits and products during the study.
10)Able to comply with the study requirements for 6 consecutive months.
11)Subjects willing to refrain from other AGA/Female pattern hair loss treatments during the entire study duration.
12)Have no clinically significant disease or abnormal laboratory results taken at the screening visit.
13)Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study.
14)Subjects who are not on crash dieting
 
 
ExclusionCriteria 
Details  1)Subjects who are undergoing hair growth treatment 3 months before screening into the study.
2)Subjects who have scalp conditions such as folliculitis, seborrheoic psoriasis of scalp, seborrheoic dermatitis and lichen planopilaris at the time of screening.
3)Subjects who have alopecia areata of scalp hair and scarring alopecia due to any cause such as DLE, SLE and lichen planus.
4)Subjects who have undergone hair straightening using hot iron or chemicals within 3 months.
5)Subjects who have undergone treatments of cancer chemotherapy within 6 months before starting study or plan to undergo the same during study terms.
6)Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
7)Subjects who have had hair transplantation treatment.
8)Subjects who take pharmaceutical products that may cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia.
9)A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
10)Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
11)Subjects who are on oral multivitamin tablets containing biotin, zinc, selenium and unwilling to stop the usage 1 month before enrollment into study and throughout the study duration.
12)Subjects with hypertension and thyroid as confirmed by history or blood screening.
13)Female subjects who have been pregnant in last 1 year or lactating or nursing as established by medical history or planning to become pregnant during the study period.
14)Female subjects with the complaint of post pregnancy hair fall.
15)Subjects who have undergone hair dyeing in last 1 month or plan to undergo the same during the study period.
16)Subjects who suffered with acute severe illness in past 3 months as established by the medical history.
17)Chronic illness which may influence the cutaneous state.
18)Subjects participating in other similar cosmetic or therapeutic trial.
19)Any underlying uncontrolled medical illness including diabetes mellitus, HIV, hepatitis, anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in scalp hair density as compared to baseline, and comparable improvement in hair density compared to the comparator (benchmark) product in male subjects
Significant improvement in scalp hair density as compared to baseline, and comparable improvement in hair density compared to the comparator (benchmark) product in female subjects.
 
6 Months for each subject
 
 
Secondary Outcome  
Outcome  TimePoints 
Significant improvement in scalp hair growth as compared to baseline, and comparable improvement in hair growth compared to the comparator (benchmark) product in male subjects
 Significant improvement in scalp hair growth as compared to baseline, and comparable improvement in hair growth compared to the comparator (benchmark) product in female subjects.

 
6 months for each subject 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="168" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/08/2016 
Date of Study Completion (India) 25/10/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Study Purpose: The study aims at assessing the safety and efficacy of the investigational product for scalp hair growth and hair density as compare to the respective comparator (benchmark) product in male & female subjects

Study Design: A single blinded (Investigator Blinded), randomized, comparative, monocentric, four arms efficacy study.

Study Duration: 183 days (approximately 6 Months) for each subject.

Total No. of visits: 15

Sample size: 200 Subjects

Main Assessment Parameters:

1) Phototrichogram assessment for hair growth, density and A:T ratio.

2) Dermatologist’s assessment of hair and scalp- dermatologist’s assessment for efficacy.

3) Subject’s self assessment, habit questionnaire and comb test.

4) Assessment for product safety by analyzing application site reaction (by dermatologist and subject).

Results: Significant improvement was observed in scalp hair density as compared to baseline and comparable improvement was observed in hair density compared to the comparator product in male and female subjects. The hair density improvement was more in percentage in female subjects. Significant improvement of scalp hair growth as compared to baseline,and comparable improvement in hair growth compared to the comparator product was seen in male and female subjects. Singnificant improvement was observed in scalp and hair condition compared to baseline on application of the test product,and improvement was also compared with the comparator product in male and female subjects.The hair growth and condition was improved and gave good results in male and female subjects.

 
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