| CTRI Number |
CTRI/2018/05/014155 [Registered on: 29/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/08/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Claim Efficacy] |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy study of the given sample-Hair styling gel |
|
Scientific Title of Study
|
Open and one arm study of efficacy and tolerability of cosmetic Formulations (Hair Styling Gel) for Wet Hold and damage control on 30 healthy human subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Medhekar |
| Designation |
Principal Investigator |
| Affiliation |
Sanity Lifesciences Pvt.Ltd |
| Address |
Sanity Lifesciences Pvt.Ltd B-15 Vigneshwar Chsl M.B. Estate Virar-(W) Thane- 401303 Thane MAHARASHTRA 401303 India MAHARASHTRA 401303 India
Thane
MAHARASHTRA
Thane- 401303
India |
| Phone |
9820321430 |
| Fax |
|
| Email |
sudhir.medhekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Medhekar |
| Designation |
Principal Investigator |
| Affiliation |
Sanity Lifesciences Pvt.Ltd |
| Address |
Sanity Lifesciences Pvt.Ltd B-15 Vigneshwar Chsl M.B. Estate Virar-(W) Thane- 401303 Thane MAHARASHTRA 401303 India MAHARASHTRA 401303 India
Thane
MAHARASHTRA
Thane- 401303
India |
| Phone |
9820321430 |
| Fax |
|
| Email |
sudhir.medhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Medhekar |
| Designation |
Principal Investigator |
| Affiliation |
Sanity Lifesciences Pvt.Ltd |
| Address |
Sanity Lifesciences Pvt.Ltd B-15 Vigneshwar Chsl M.B. Estate Virar-(W) Thane- 401303 Thane MAHARASHTRA 401303 India MAHARASHTRA 401303 India
Thane
MAHARASHTRA
Thane- 401303
India |
| Phone |
9820321430 |
| Fax |
|
| Email |
sudhir.medhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Godrej Consumer Products Ltd. Pirojshanagar Eastern Express Highway, Vikhroli (East), Mumbai – 400079 |
|
|
Primary Sponsor
|
| Name |
Godrej Consumer Products Ltd |
| Address |
Godrej Consumer Products Ltd Pirojshanagar Eastern Express Highway Vikhroli,East Mumbai 400079 |
| Type of Sponsor |
Research institution |
|
|
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 Sudhir Medhekar |
Kasturmahal Polyclinic |
Flat No.3 , C wing, Kasturmahal Bldg, above kamal photo studio, Opp.Canara Bank , Sion
Mumbai (Suburban)
MAHARASHTRA |
9820321430
sudhir.medhekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanity Life Sciences - Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
30 Male healthy human subjects with damaged hair. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hair styling gel (Batch Number - 223/244)
|
Aqua, VP/VA Copolymer, Glycerin, Acrylates Crosspolymer-3, PEG-40
Hydrogenated Castor Oil,Aminomethyl Propanol, Glycerin &
GlycerylPolyacrylate, DMDM Hydantoin, Carbomer, Disodium EDTA,
EthylhexylMethoxycinnamate, Hydrolyzed Tomato Skin, Tocopheryl Acetate,
Hibiscus Rosa-Senensis Extract, Patent Blue 5 (CI 42051), Perfume/ Parfum |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Volunteer ( Male ) in generally good health.
2. Volunteer between the ages of 18 and 50 years.
3. Volunteer has not participated in a similar
clinical investigation in the past three months.
4. Volunteer willing to give a written informed consent,
agrees for audio video consenting procedures and come for
regular observation.
5. Volunteer having mild to moderate hair damage
6. Volunteer with very dry hair |
|
| ExclusionCriteria |
| Details |
1. Known history or present condition of allergic response to
any cosmetic products.
2. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous
manifestations on the scalp), which would interfere with the
test readings.
3. Medications (e.g. steroids or antihistamines), which
would compromise the study.
4. Known alcohol or drug abuse.
5. Any history of underlying uncontrolled medical illness including
diabetes, liver disease or any other serious medical illness
6. Volunteers participating in any other cosmetics or
any other clinical trial.
7. Hypersensitivity to any of the tested products.
8. Use of Hormonal Contraceptives either Oral or Implants |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy evaluation of cosmetic formulation (Hair Styling gel) in conferring wet hold damage control on 30 healthy human subjects. |
Visit 1- Screening and application , Visit 2 – next
day , Visit 3 – 7th day , Visit 4 – 14th day.
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2018 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Each party is willing to disclose Confidential Information to the other on the following terms: 1. The recipient will receive, maintain and hold the Confidential Information in strict confidence and use at least the same level of care in safeguarding it as that it uses with its own Confidential Information and material of a similar nature. 2. The recipient will use the Confidential Information so disclosed exclusively for the purposes relating to testing of the products. 3. It is expressly understood that SPONSOR cannot publicise, under any circumstances, the results of the competitors’ products. However, SPONSOR has the right to make general claims on their own products. 4. Sanity Lifesciences Pvt. Ltd. does not have the right to publicise/publish the results of the study without SPONSOR’s consent. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a prospective , open label, one arm efficacy test. This will be 15 Days study. The subjects will be assessed by the dermatologist on Visit 1- Screening and application , Visit 2 – next day , Visit 3 – 7th day , Visit 4 – 14th day. |