| CTRI Number |
CTRI/2018/01/011454 [Registered on: 19/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FMCG] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the dermatological safety of hair oil and shampoo on women with sensitive scalp conditions. |
|
Scientific Title of Study
|
A single arm, single centered clinical study on healthy human subjects, to evaluate the suitability of the product regime on sensitive scalp. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/436, Version: 01, Dated: January 08, 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vihanga Khanna |
| Designation |
Principal Inverstigator |
| Affiliation |
Kelkar Education Trusts |
| Address |
Kelkar Education Trusts, Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E)
Mumbai
MAHARASHTRA
400081
India |
| Phone |
022-25639644 |
| Fax |
|
| Email |
vihanga@kelkarcosmetology.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manmohan Sharma |
| Designation |
Group Leader |
| Affiliation |
Dabur India Limited |
| Address |
Dabur India Limited,
Plot No. 22, Site IV,
Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
0120-3378591 |
| Fax |
|
| Email |
manmohan.sharma@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Manmohan Sharma |
| Designation |
Group Leader |
| Affiliation |
Dabur India Limited |
| Address |
Dabur India Limited,
Plot No. 22, Site IV,
Sahibabad
UTTAR PRADESH
201010
India |
| Phone |
0120-3378591 |
| Fax |
|
| Email |
manmohan.sharma@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited,
Plot No. 22, Site IV,
Sahibabad, Ghaziabad - 201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Plot No. 22, Site IV, Sahibabad, Ghaziabad - 201010 |
| 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 |
| Vihanga Khanna |
Kelkar Education Trusts, Scientific Research Centre |
4th Floor, V. G. Vaze College Campus, Mulund (E)
Mumbai
MAHARASHTRA |
022-25639644
vihanga@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kelkar Education Trusts |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Total 35 female subjects, from 19 to 35 years (both inclusive) of age, with sensitive scalp condition were enrolled in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable. |
Not applicable. |
| Intervention |
Vatika B&B Hair Oil and Shampoo |
Vatika B&B Hair Oil (VBB02) containing Coconut Oil, Sesame Oil, Vitamin E Acetate, Macadamia Oil, Soybean Oil, Avocado
Oil, Jojoba Oil,
Bisabolol, Wheat Extract, Calendula Extract,
Matricaria Extract, Fucus Extract, ter-Butylhydroquinone, Perfume.
Vatika B&B Shampoo (VBB01) containing Aqua, Cocoamidopropyl Betaine, Sodium Lauroyl Sarcosinate, PEG-80 Sorbitan Laurate, Glycerine, PEG-4 Rapeseedamide, PEG-150 Distearate, Parfum, Niacinamide, Polyquaternium 10, Phenoxyethanol, Sodium Benzoate, Citric Acid, Disodium Edetate, Olive Extract |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Volunteer in generally in good health.
2) Volunteer with sensitive scalp condition.
3) Healthy female volunteer between 19 to 35 years of age (both inclusive)
4) Volunteer willing to give a written informed consent and come for regular observation.
5) The volunteer has not participated in a similar clinical investigation in the same past four weeks. |
|
| ExclusionCriteria |
| Details |
1) A known history or present condition of an 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) Pregnant or lactating.
5) Volunteer viewed by the investigator as not being able to complete the study or participating in another study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of the Product Regimen (shampoo & oil) on healthy human female subjects with sensitive scalp condition. |
Screening, week 0, week 2 and week 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate overall safety of the subject throughout the study. |
Screening, week 0, week 2 and week 4. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2015 |
| Date of Study Completion (India) |
04/03/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Result of the study of this clinical study may be used for publishing scientific paper and data.All the data generated on the study will be exclusive property of sponsor and no publication can be done with out sponsors written approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The clinical study was initiated for estimation of the overall dermatological safety of product regimen [Vatika B&B Shampoo (VBB01) and Vatika B&B Hair Oil (VBB02)]. 35 healthy female subjects (with sensitive scalp condition), between 19 to 35 years of age (both inclusive), were enrolled in the study and all 35 respondent subjects completed the study. Subjects were screened basis predefined inclusion and exclusion criteria and were called for dermatological observations and subject self-assessment at week 0, week 2 and week 4.Based on the results, test products were found to be overall dermatologically safe. Parameters evaluated were subject self-assessed and dermatological observed, which included safety parameters (burning, itching, stinging and redness) and overall scalp condition. |