| CTRI Number |
CTRI/2013/03/003476 [Registered on: 12/03/2013] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmoceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety and efficacy of soybean milk culture Filtrate for anti hair fall and hair regrowth in healthy Indian human volunteers. |
|
Scientific Title of Study
|
A Prospective phase II Open label, monocentric,single arm study to evaluate the safety and efficacy of soybean milk culture Filtrate for anti hair fall and hair regrowth in healthy Indian human volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/ICHS/2012-01,version 1.0,dated 31 Jan 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt,Ltd |
| Address |
MS Clinical Research Pvt,Ltd
Mezzanine Floor,Clasic Court,9/1,Richmond Road Bangalore-560025
Bangalore Karnataka.
MS Clinical Research Pvt,Ltd
Mezzanine Floor,Clasic Court,9/1,Richmond Road Bangalore-560025
Bangalore Karnataka.
Bangalore
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt,Ltd |
| Address |
MS Clinical Research Pvt,Ltd
Mezzanine Floor,Clasic Court,9/1,Richmond Road Bangalore-560025
Bangalore Karnataka.
MS Clinical Research Pvt,Ltd
Mezzanine Floor,Clasic Court,9/1,Richmond Road Bangalore-560025
Bangalore Karnataka.
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt,Ltd |
| Address |
MS Clinical Research Pvt,Ltd
Mezzanine Floor,Clasic Court,9/1,Richmond Road Bangalore-560025
Bangalore Karnataka.
MS Clinical Research Pvt,Ltd
Mezzanine Floor,Clasic Court,9/1,Richmond Road Bangalore-560025
Bangalore Karnataka.
KARNATAKA
560025
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
mukesh.ramnane@mscr.in |
|
|
Source of Monetary or Material Support
|
| Study sponsor:Ichimaru Pharcos Co Ltd,318-1 Asagi Motosu-Shi,Gifu 501-0475,Japan.
Study Site:MS Clinical Research Pvt,Ltd,Bangalore India. |
|
|
Primary Sponsor
|
| Name |
Ichimaru Pharcos Co Ltd |
| Address |
Ichimaru Pharcos Co Ltd,318-1 Asagi Motosu-Shi,Gifu 501-0475,Japan. |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukesh Ramnane |
MS Clinical research Pvt.Ltd. |
Mezzanine floor, Classic court 9/1,Richmond road,bangalore
Bangalore
KARNATAKA |
918040917253
918041125934
mukesh.ramnane@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LIFELINE ETHICS COMMITTEE,Bangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anti hair fall and hair regrowth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Soybean milk culture filtrate. |
route of application- topical
approximately 15 weeks i.e., 105 days for each volunteer, twice application daily 9in morning and evening on scalp.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Male and Female subjects in general good health.
•Subjects in the age group 20-65 years.
•Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
•Subjects willing to abide by and comply with the study protocol.
•Subjects who have not participated in a similar investigation in the past four weeks.
•Female Subjects falling under class 2 - class 5 of hair loss severity grade (evaluated as per standard photonumeric 6 point scale)
•Male subjects falling under type 3 vertex – type 5 of hair loss severity grade (evaluated as per Norwood scale)
•Subjects who agree to have hair wash everyday
•Subjects who are not on crash dieting
•Subjects who are willing to refrain from using hair dyes/henna at the time of screening and throughout the study.
•Subjects willing not to tie hair tightly.
•Subjects willing to refrain from any type of hair treatment like head massage, oil application (on scalp), perming, etc. during the study duration.
|
|
| ExclusionCriteria |
| Details |
•Subjects who are undergoing hair growth treatment 3 months before screening into the study
•Subjects who have disorders like eczema, scalp infection, etc at the time of screening.
•Subjects who have alopecia areata of scalp hair.
•Subjects who have undergone hair straightening using hot iron or chemicals within 3 months.
•Subjects who have treatments of actinotherapy or cancer chemotherapy within 6 months before starting study or have a plan to do treatments of them during study terms.
•Subjects who have history of alcoholism and/ or psychiatric disorder
•Subjects who use hairpiece during study terms
•Subjects who have had hair transplant
•Subjects who take pharmaceutical product which cause hirsutism or sparsed fur (ex. phenytoin)
•A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
•Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
•Subjects who are on oral multivitamin tablets containing biotin, zinc, selenium and unwilling to stop the usage 1 month before enrollment into study and through out the study duration.
•Subjects who are pregnant or become pregnant during study terms, lactating or nursing as established with medical history
•Chronic illness which may influence the cutaneous state.
•Subjects participating in other similar cosmetic or therapeutic trial.
•Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To evaluate the efficacy of Soybean milk culture filtrate in anti hair fall and hair regrowth in comparison to baseline |
15 weeks for each subject, Evaluations performed on Day 3,14,56,59,84,87 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To evaluate the safety of Soybean milk culture filtrate in the study.
•To evaluate the overall improvement in hair condition. |
15 weeks for each subject, Evaluations performed on Day 3,14,56,59,84,87 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/02/2013 |
| 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="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Objectives: To evaluate the efficacy of Soybean milk culture filtrate in anti hair fall and hair regrowth in comparison to baseline. To evaluate the safety of Soybean milk culture filtrate in the studyTo evaluate the overall improvement in hair condition. Study Population: 40 Subjects (Male :Female) 1:1 ratio.Study Duration:105 day’s(approximately 15 weeks),for each subject which includes 09 visits.visit schedule: 1st visit will be a screening visit during which the sensitivity test (48 hours closed patch test) for the test product will be performed. The 48 hour closed patch will be evaluated for skin irritation on visit 2(2 days from patch application). This will be followed by a 2 week wash-in period. The eligible subjects will be enrolled on Visit 3(Day 1). Visit 5(Day 14) will be a compliance visit. Visit 3,6,8 will be followed by Visit 4,7,9 on the third successive day of visit 3, visit 6 and visit 8 respectively. Phototrichogram imaging (all parameters)Will be done on visit 4,7 and 9. Phototrichogram imaging for hair growth will be done on visit 3,4,6,7,8 and 9.Imaging Nikon D60 will be done on visit 3,6 and 8. Dermatological assessment for safety and site appilication reaction will be carried out in all visits.
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