| CTRI Number |
CTRI/2017/12/010907 [Registered on: 18/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [hair remover ( cosmetics)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the efficacy of hair removing cream on healthy human subjects. |
|
Scientific Title of Study
|
To evaluate the efficacy of hair removing cream formulations for hair. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/333 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMA AYACHIT |
| Designation |
Principal Investigator |
| Affiliation |
Kelkar Education Trusts, Scientific Research Center |
| Address |
Kelkar Education Trusts, Scientific Research Center, 4th Floor, V.G. Vaze College Campus, Mulund(E), MUMBAI
Mumbai
MAHARASHTRA
400081
India |
| Phone |
022-25639644 |
| Fax |
|
| Email |
uma@kelkarcosmetology.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manmohan Sharma |
| Designation |
Group Leader |
| Affiliation |
Dabur India Ltd. |
| Address |
Plot No.22, Site-IV, Sahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378591 |
| Fax |
|
| Email |
manmohan.sharma@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Manmohan Sharma |
| Designation |
Group Leader |
| Affiliation |
Dabur India Ltd. |
| Address |
Plot No.22, Site-IV, Sahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378591 |
| Fax |
|
| Email |
manmohan.sharma@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Ltd,
Plot No.22, Site-IV, Sahibabad, Ghaziabad-201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Plot No. 22, Site-IV, Sahibabad, Ghaziabad |
| 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 |
| Uma Ayachit |
Kelkar Education Trust, Scientific Research Centre |
4th Floor,V.G. Vaze College Campus,Mulund(E),MUMBAI
Mumbai
MAHARASHTRA |
022-25639644
uma@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kelkar Eduction Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hair Removal cream |
The Hair removal cream contains Aqua, Cetostearyl Alcohol,Thioglycollic acid, Paraffinum Liquidum,Urea,
Calcium Hydroxide,Cetereath-20,Talc,Sodium hydroxide,Perfume,Glycerin,
Magnesium Trisilicate,
Sodium Magnesium Silicate,
Propylene Glycol,
Acrylates Copolymer,
Titanium dioxide,
Sodium Gluconate,
Jojoba Oil,Liquorice Extract
|
| Comparator Agent |
Hair Removal cream |
The Hair removal cream contains Aqua, Cetostearyl Alcohol,Thioglycollic acid, Paraffinum Liquidum,Urea, Calcium Hydroxide,Cetereath-20,Talc,Sodium hydroxide,Perfume,Glycerin, Magnesium Trisilicate, Sodium Magnesium Silicate, Propylene Glycol, Acrylates Copolymer, Titanium dioxide, Sodium Gluconate, Jojoba Oil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects in generally good health
2.Subjects in the age group of 18-35 years.
3.Subjects with moderate hair growth on lower outer forearms.
4.Subjects without any cuts, marks and open wounds on lower outer forearms.
5.Subject has not participated in a similar investigation in the past four weeks.
6.Subjects have not used a similar product for the last four weeks.
7.Subjects willing to give a written informed consent and come for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives,hydroquinone, vitamin C, Niacin amide,retinol, soy etc.
2.Currently or has been using topical retinoids, alpha-hydroxy and/or beta-hydroxy acids,hydroquinone or any whitening/Fairness preparation in any form (cleanser, toner, cream
or soaps) within the last 1 month.
3.Currently or has been undergoing dermatologist skin treatments or procedures within the last 1 month.
4.Currently or has been involved in another skin care clinical investigation within the last 3 months.
5.Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis,
rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with
the outcome of the study as determined by the investigator.
6.Subjects with scars which could interfere with expert grader and/or instrumental
evaluations.
7.Subjects who are nursing as determined by the investigator interview during screening or
pregnant as determined by the Urine pregnancy testing after screening.
8.Subjects viewed by the investigator as not being able to complete the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of hair removing cream and skin darkening effect on Repetitive usage on healthy human subjects |
Day 1, Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety of the subject throughout the study |
Day 1, Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/03/2012 |
| Date of Study Completion (India) |
19/05/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Result s of the study of this clinical Trial may be used for publishing scientific papers and data. All the data generated on the trial will be exclusive property of sponsor; and no publication can be done without sponsors written approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study was designed to test the safety & efficacy of topical products provided by Dabur India Limited on healthy human subjects. 24 female subjects were enrolled in the study, and 23 completed the study. The study was conducted over a period of approximately 60 days for each subject. the test product was patched on the arms of the subject . The skin was evaluated for signs of irritation identified under Erythema and odema, using Draize’s scale. After patch removal, the sample test product applied on skin was applied for 3-6 minutes and observation taken by dermatologist, self subject observation and instrument test on corneometer, hair analyzer , Mexameter and chromometer . Post product removal, observation taken for immediate reactions and 30 days & 60 days post removal for delayed reactions. All the test products were deemed to be dermatologically safe as per their classification into non irritant category at all time points of evaluation. The hair was removed within the time range of 3-6 minutes by test products and skin fairness, glow improves. |