FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013975 [Registered on: 18/05/2018] Trial Registered Retrospectively
Last Modified On: 27/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmeceutical]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is a study on the effectiveness of an Oral supplement on hair growth in women when compared with a marketed product. 
Scientific Title of Study   A Double-blind, Randomized, Controlled Evaluation of the Effectiveness of an Oral Supplement on Hair Growth and Decreased Hair Shedding in Women with Thinning Hair.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL/67/SBA/AUG/17V1.303-AUG-17  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Madan Kumar BJ 
Designation  Consultant 
Affiliation  Dr Hair and Skin Clinic 
Address  # 23, 12th Cross, Palace Guttahalli Main Road, Behind Coffee Day, Malleswaram West.

Bangalore
KARNATAKA
560003
India 
Phone  9008508578  
Fax    
Email  mady.kumar40@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Prachi Lad 
Designation  Team Lead 
Affiliation  ClinWorld (P) Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  prachi@clinworld.org  
 
Details of Contact Person
Public Query  
Name  Ms Prachi Lad 
Designation  Team Lead 
Affiliation  ClinWorld (P) Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore.

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  prachi@clinworld.org  
 
Source of Monetary or Material Support  
Atlantic Coast Brands. 100 Town Square Place, 6th Floor, Jersey City, New Jersey, 07310. 
 
Primary Sponsor  
Name  Atlantic Coast Brands 
Address  100 Town Square Place, 6th Floor, Jersey City, New Jersey, 07310.  
Type of Sponsor  Other [International beauty company that builds iconic beauty brands.] 
 
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 Madan Kumar BJ  Dr Hair and Skin Clinic  No. 23, 12th Cross, Palace Gutahalli Main Road, Behind Coffee Day, Malleswaram West.
Bangalore
KARNATAKA 		 9008508578

mady.kumar40@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Females with self perceived mild to moderate hair thinning. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active Comparator  One soft gel capsule each twice daily for 120 days. 
Intervention  SBA-1001 Oral Hair Supplement  One soft gel capsule each twice daily for 120 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1 Healthy females, minimum age greater than equal to 20 years and maximum age less than equal to 55 years of age.
2 Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
3 Self-perceived mild to moderate hair thinning as assessed through a questionnaire associated with diet, stress, or hormonal influences.
4 Willing to allow hair shampooing as per study procedure.
5 Willingness to maintain cut of hair over the duration of the study, and to maintain all other general hair regimens.
6 Compliance to all study procedures including those required for Trichoscan measurements.
7 Has given voluntary, written, informed consent to participate in the study.
8 Agree to not substantially change diet, medications or exercise routine for the duration of the study.
9 Willing to add the provided oral supplement to their daily routine.
10 Willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam.
11 Females with Fitzpatrick I-IV photo skin types and as per Savin hair loss classification.
12 Willingness to have digital photography of the target area of scalp for hair counts.
13 Willingness to have ten (10) terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements.
14 Willingness to have their hair washed (shampooed) with Keranique Scalp Replenishing Shampoo – Damage Control over a sink containing a gauze for hair shedding counts.
15 Willingness of subjects who have color-treated hair can have the color treatment performed, but with no interference in the study procedures such as Modified hair wash test. 
 
ExclusionCriteria 
Details  1 Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
2 Women who have begun hormonal birth control or hormone replacement within 6 months of randomization.
3 Subjects taking vitamin supplements, including multi-vitamins, within 2 weeks of randomization.
4 Subjects having undergone a form of treatment for thinning hair, including prescription drugs such as Minoxidil, Finasteride, or any 5α-reductase inhibitor or light therapy within 6 months of randomization.
5 Medical history of diagnosed hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia, and telogen effluvium trichotillomania (compulsive hair pulling) as determined on initial study assessment by the Investigator.
6 Subjects currently using hair extensions.
7 Subjects with psoriasis or any active dermatological condition of the scalp at randomization that in the opinion of the qualified investigator would interfere with the clinical evaluations.
8 Subjects using or having used, within the last 6 months, any prescription medication known to affect the hair growth cycle.
9 Medical history of thyroid disorders.
10 Unstable medical conditions as determined by qualified investigator, or any self-reported uncontrolled disease, such as diabetes, hypertension. Medical conditions that are under control with or without treatment will be considered on an individual basis by investigators.
11 Females with self-reported active hepatitis, immune deficiency, HIV or Autoimmune disease.
12 Clinically significant abnormal laboratory results at screening.
13 Participation in a clinical research trial within 30 days prior to randomization.
14 Allergy or sensitivity to study supplement ingredients.
15 Individuals who are cognitively impaired and/or who are unable to give informed consent.
16 Any other condition which in the Investigator’s opinion may adversely affect the subject’s ability to complete the study or its measures or which may pose significant risk to the subject.
17 Subjects with any known allergy or sensitivity to any shampoo/conditioner product.
18 Subjects who have experienced a known stressful event within the last 6 months such as Death in family, miscarriage, etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Change in Visible Hair density by Macro photography.
2 Change in Hair density, hair diameter, hair growth rate and anagen/telogen ratio by Trichoscan HD analysis.
3 Change in number of hair shed by Modified hair wash test.  		 1 Macro photography(Baseline,Day30,Day60,Day90,Day120 and Day180).
2 Trichoscan HD analysis(Baseline,Day120 and Day180).
3 Modified hair wash test(Baseline,Day10,Day20,Day30,Day40,Day50,Day60,Day70,Day80,Day90,Day100,Day110,Day120,Day130,Day140,Day150,Day160,Day170 and Day180).  
 
Secondary Outcome  
Outcome  TimePoints 
1 Global assessment of improvement in hair growth using 7-point scale.
2 Savin Scale by direct visual examination.
3 Subjective evaluation of hair condition according to self-analysis of hair growth by quality of life questionnaire.
4 Subject satisfaction of hair condition according to questionnaire. 		 1 Global assessment of improvement in hair growth using 7-point scale(Baseline,Day30,Day60,Day90,Day120 & Day180).
2 Savin Scale by direct visual examination(Baseline,Day30,Day60,Day90,Day120 & Day180).
3 Subjective evaluation of hair condition according to self-analysis of hair growth by quality of life questionnaire(Day30,Day60,Day90,Day120 & Day180).
4 Subject satisfaction of hair condition according to questionnaire(Day30,Day60,Day90,Day120 & Day180). 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   16/08/2017 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Might be published later. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A prospective, randomized, double blind, active controlled study in 40 adult female volunteers in the age group of greater than equal to 20 and less than equal to 55 years with self perceived mild to moderate hair thinning will be conducted to evaluate the effectiveness of SBA-1001 Oral Supplement. The individual subject participation will be for 120 days, may be extended to 180 days as per Sponsor discretion based on interim results. The primary endpoints for the study are changes in the number of terminal hair by macro photography. trichoscan analysis and modified hair wash test. The secondary endpoints are improvement in hair growth using 7-point scale, Savins scale, self analysis of hair growth, subject satisfaction of hair condition questionnaire. Statistical analysis will be performed as listed in the protocol. 
Close