| CTRI Number |
CTRI/2017/12/011027 [Registered on: 29/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Anti ageing (cosmetics)] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of antiageing cream. |
|
Scientific Title of Study
|
To evaluate the efficacy of the cream formulation in reducing skin wrinkles, increasing skin firmness, smoothness and hydration. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/272, Version 2.0, Dated31/05/2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMA AYACHIT |
| Designation |
Principal Investigator |
| Affiliation |
Kelkar Education Trusts |
| Address |
Kelkar Education Trusts, Scienticfic Research Centre, 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 |
Dabur India Limited, DRDC, 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 |
Dabur India Limited, DRDC, 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 Limited, Plot no. 44, site-IV, shaibabad-201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Plot No. 44, 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 |
| Uma Ayachit |
Kelkar Education Trust, Scientific Research Centre |
Kelkar Education Trusts, Scienticfic 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 |
Subjects in generally good health condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti ageing cream |
The anti ageing cream contains Aqua, Propylene glycol,Xantham Gum,
Isopropyl myristate,
Butylated hydroxy toline,Cetostearyl alcohol,
Jojoba oil,
Glyceryl mono stearate, Talcum powder,
Arlacel 165,
Turmeric oleo resin,Lecithin,
Gatuline RC,
NIACINAMIDE I.P.
Preservative,
Light liquid paraffin,
Cyclomethione,
Perfume. |
| Comparator Agent |
NOT APPLICABLE (SINGLE ARM STUDY) |
NOT APPLICABLE (SINGLE ARM STUDY) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.subjects in generally good health
2.Subjects in the age group of 30-50 years.
3.Subjects should have minimum number of fine lines, mild to moderate.
4.Subjects having a wrinkle and five volunteers with deep wrinkles will be selected for visiometer.
5.Must have at least 2 hyperpigmentation lesions (freckles, lentigen, periorbital melanosis) each at least 3mm on the face. Subjects who exhibit moderate hyperpigmentation with a score of 3 but no greater than 4 (see scale in section 7.3.D.1).
6.Subject has not participated in a similar investigation in the past four weeks.
7.Subjects have not used a similar product for the last four weeks.
8.Subjects willing to give a written informed consent and come for regular follow. |
|
| 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, facial lotion, cream or soaps) within the last 1 month.
3. Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.
4.Currently or has been involved in another facial skin care clinical investigation within the last 3 months.
5.Subjects who have pre-existing or dormant facial 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 excessive facial hair or scars (including acne scars), which could interfere with expert grader and/or instrumental evaluations.
7.Subjects having melasma and severe photo damage.
8.Subjects who are nursing as determined by the investigator interview during screening or pregnant as determined by the Urine pregnancy testing after screening.
9.Subjects viewed by the investigator as not being able to complete the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of the anti ageing cream in reducing skin wrinkles, hyperpigmentation and increasing skin firmness, smoothness and hydration n repetitive usage on healthy human subjects |
Day 1, Day 2, Week 2, Week 4, Week 8 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the subject throughout the study |
Day 1, Day 2, Week 2, Week 4, Week 8 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2011 |
| Date of Study Completion (India) |
07/10/2011 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results of the study of this clinical trial may be used for publishing scientific papers and data. All the data generated n 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 antiageing product provided by Dabur India Limited on healthy human subjects. 35 subjects (17 male & 18 female) were enrolled in the study, and 32 subjects ( 14 male & 18 female) completed the study. The study was conducted over a period of approximately 84 days for each subject. the evaluation was done by dermatologist , subject evaluation and by instrument (cutometer, visiometer, corneometer, visioscan, mexameter, chromameter). The product need to use on daily twice on clean face and observation taken by subject, dermatologist & instrument at all the visits. The results of the study showed that the formulation has the antiageing potential, the product improves the skin elasticity , firmness and reduce the wrinkles on face and the test product was also found to be safe in all the subjects during the study period. |