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CTRI Number  CTRI/2018/03/012303 [Registered on: 05/03/2018] Trial Registered Retrospectively
Last Modified On: 10/02/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmaceutical]  
Study Design  Other 
Public Title of Study   Evaluation of the safety and efficacy of the product in subjects experiencing hair loss 
Scientific Title of Study   Clinical evaluation of the safety and efficacy of the investigational product containing herbal actives for hair growth and hair quality in subjects experiencing hair loss  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/DRHO/2017-01 Version 1.0 Dated 10 Nov 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sapna R 
Designation  Pricipal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Dermatology evaluation room, 1st floor,327/15,1st main road,Cambridge layout Ulsoor

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

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax  08041125934  
Email  sapna.r@mscr.in  
 
Details of Contact Person
Public Query  
Name  Ritambhara 
Designation  Manager 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Dermatology evaluation room, 1st floor,327/15,1st main road,Cambridge layout Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax  08041125934  
Email  ritambhara@mscr.in  
 
Source of Monetary or Material Support  
Dabur Research Foundation, Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), India.  
 
Primary Sponsor  
Name  Dabur Research Foundation 
Address  Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), 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  Dermalogical Evaluation room, first floor, 327/15, 1st main road , cambridge layout,ulsoor
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  Subjects with hair fall above 20 hair fall in comb test and subjects with follicular density above 100-200/cm2 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1.Minoxidil Forte 5% for males 2.Minoxidil Forte 2% for females  Dose:1 ml Frequency:Once Daily Route of administration: Topical Application Duration of therapy: 90 days for each subject 
Intervention  1.Test Oil  Dose:5-8ml, depending on the length of hair. Frequency:Once Daily Route of administration: Topical Application Duration of therapy: 90 days for each subject  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Male and female subjects’ in general good health.
2.Subjects in the age group 18-45 years (both the ages inclusive).
3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
4.Subjects with hair fall- above 20 hair fall in comb test (with bulb+ without bulb)
5.Subjects with follicular density above 100-200
6.Subjects complaining of hair fall
7.Subjects complaining about hair thinning
8.Subjects who have not participated in a similar investigation in the past three months.
9.Healthy volunteers with no known allergy as established by medical history.
10.Subjects who do not smoke or drink
11.Subjects who are not crash dieting.
12.Subjects who agree to refrain from using hair dye / hair color during the study period.
13.Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration.
14.Subjects with regular oiling habits
 
 
ExclusionCriteria 
Details  1.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
2.Subjects who have had hair transplant.
3.Subjects who take pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia
4.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
5.Subjects having any active scalp diseasewhichmayinterfere in the studydermatologist’sjudgement.
6.Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
7.Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
8.Subjects consuming alcohol and smoking
9.Subjects on oral medications which will compromise the study.
10.Subjects who are pregnant or lactating or nursing as established with medical history.
11.Under medical treatment for hair problems
12.Undergoing any chemical hair salon treatment-
straightening / perming / colour
13.Menopausal female subjects as determined by medical history.
14.Pregnant female subjects as determined by UPT test
15.Chronic illness which may influence the cutaneous state. Subjects participating in other similar cosmetic or therapeutic trial within last three months
16.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe 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 hair fall reduction, improvement in hair growth, improvement in hair density, hair thinning, thickness and hair strength in comparison to baseline and observational group
Equivalence or superiority of efficacy in hair fall reduction improving hair growth, improvement in hair density, thickness and hair strength in comparison to comparator group.
 		 Approximately 108 days for each subject 
 
Secondary Outcome  
Outcome  TimePoints 
Significant product tolerance in terms of local intolerance and product related AE reported during the study  Approximately 108 days for each subject 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   27/11/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Primary objectives:

·        To assess the efficacy of test products in hair fall reduction and improving hair growth

·        To assess the efficacy of test products in improving hair density and thickness

·        To assess the efficacy of test product in providing hair strength

·        To evaluate the impact of the test product on hair thinning

Secondary objectives:

·        To evaluate the safety of the test products with respect to local intolerances and adverse events (product related) reported during the study

·      To evaluate overall improvement in hair quality such as anchorage strand breaks/from root, dryness, texture, detangling, shine, reduction in graying etc.

·           Improvement in scalp condition and perceived benefits as per subject’s sensorial assessment.

·           Subject self assessment for hair growth, density and quality

.         To evaluate the product acceptance as per subject’s sensorial assessment.

Study Duration:

Approximately 108 days (15 weeks) for each subject.


Sample Size:

Total of 90 subjects divided equally into three groups.


Study Design:

Single blinded (Investigator blinded), randomized, comparative, monocentric, three arms efficacy study. pan>ts divided equally into three groups.


Study Visits:

Total 10 Visits.


Main Assessment Parameters:

Primary Assessments:

Efficacy assessment by Dermatologist:

  1. Dermatologist’s assessment for efficacy
  2. Phototrichogram imaging for density, hair length (hair growth), A: T ratio and Ratio of Vellus and Terminal hair
  3. Hair fall by comb test- Test for hair fall from root, hair breakage
  4. Hair Thinning measurement as per the photonumeric linear scale (10 point scale)
  5. Hair fall by pull test- test for anchorage
  6. Image transition matrix- Improvement in hair thinning

 

Instrumental Measurements:

  1. Follicular Density by Phototrichogram
  2. Assessment of hair growth rate by Phototrichogram
  3. A:T ratio by Phototrichogram
  4. Hair thickness using Casalite nova.
  5. Tensile strength

 

 

Secondary Assessments:

1.      Safety Assessment by dermatologists

·         Local Intolerance

·         Dermat assessment for site application reaction

·         Subject assessment for site application reaction

 

2.      Norwood scale for male subjects (7 point scale) and Ludwig scale for female subjects will be used for assessments at baseline and end of the study to establish a correlation between MSCR and Standard (Norwood and Ludwig) scale.

3.      Subject self assessment for safety along with perceived benefits 

Hair sampling on baseline and end of the study will be performed and shipped to the sponsor for further analysis

 
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