| CTRI Number |
CTRI/2018/12/016533 [Registered on: 05/12/2018] Trial Registered Prospectively |
| Last Modified On: |
07/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmaceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the anti-aging efficacy of the products in healthy human volunteers |
|
Scientific Title of Study
|
Efficacy evaluation of cosmetic formulation in conferring anti-skin aging benefits in healthy human volunteers |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/ITAA/2018-04 Version 1.0 Dated 08 Nov 2018 |
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 |
First floor, Dermatologist room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| 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 |
First floor, Dermatologist room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| 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 |
First floor, Dermatologist room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@mscr.in |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences & Technology Centre Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Bangalore- 560058 Karnataka, India |
| Type of Sponsor |
Other [FMCG(Fast moving Consumer Goods)] |
|
|
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. |
First floor, Dermatologist room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
mukesh.ramnane@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Forty (40) Indian healthy human adult male and female subjects (35-60 Years) in the ratio of 1:3 will participate in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Product-PS |
One pump of the provided investigational product to be applied on face, twice daily (post morning bath and 2 hours prior to bed time after having washed face with the provided cleanser) for the entire study course. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject is willing to give a written informed consent
2.Subject is a healthy adult male and female in the age range of 35-60 years
3.Subjects with mild to moderate wrinkle crow’s feet on scale 3 and above, referring to the Modified Anti-Ageing Atlas- 6 point scale.
4.Subject has at least 2 dark spots on face that are age spots/lentigines-marks other than melasma/chloasma.
5.In case of having used fairness products/skin anti-aging products in the near past subject willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face.
6.Subjects willing to abstain from using any cosmetic/ medicinal/ ayurvedic/ natural products other than the one provided for testing on face during the study course.
7.Female subjects of reproductive age group willing to undergo UPT at time of screening visit.
8.Subject who shows good tolerance (no sensitivity symptoms) to the investigational products during the skin sensitivity test
|
|
| ExclusionCriteria |
| Details |
1.Subjects who are pregnant or lactating or contemplating pregnancy during the study course
2.Subjects with a known history or present condition of allergic response/ sensitivity to sun, sunscreens/ cosmetics/ fragrances
3.Subject having skin condition like psoriasis, atopic dermatitis or other cutaneous manifestations which would interfere with the test readings
4.Subjects on medications like retinoid, steroids, antihistamines, oral contraceptives, or those for hormonal balance which could compromise the study results
5.Subjects with tattoos, dense hair, moles, warts on face at the site of evaluation
6.Subjects having participated in a similar investigation in the past 2 month
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The dermatological safety and anti- aging efficacy of the investigational product (IP) over baseline |
Approximately 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The safety of the investigational product (IP). |
Approximately 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/12/2018 |
| Date of Study Completion (India) |
21/02/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study population
Forty
(40) Indian healthy human adult male and female subjects in the ratio of 1:3
will participate in the study. Briefing
and Informed Consent Form Procedure Study procedure,
restrictions and requirements will be explained in detail to the volunteers in
the language they understand. All queries from the subjects pertaining to the
study will be answered to their satisfaction. Subjects willing to participate
in the study will be asked to give their consent by signing the Informed
consent form, the contents of which will also be explained to them in detail,
in the language they understand. Screening Subjects providing
signature in informed consent form will be screened by the investigator as per
the inclusion exclusion criteria, medical history and skin sensitivity test.
Only subjects who meet the requirements of this section, will be enrolled in
the study. In case of subjects
having used a fairness product in the recent past, a pre-conditioning phase of
1 week is mandatory wherein they need to abstain from using any product other
than the provided mild cleanser on face. Skin
sensitivity test: About 0.01g
of investigational product will be applied at the back of subject’s ear lobe
on the right or left ear. The product needs to be retained on ear lobe for 24
hours and checked by Dermatologist for symptoms of sensitivity. Only those
subjects who show no allergic / irritation symptoms will be enrolled in the
study. Pre-conditioning
Subjects will be
provided with a mild cleansing solution to use for all cleansing purposes
during the study period. Subjects will be asked to wash their face with the
provided cleansing solution and rinse completely with water. Face needs to be
dried by gentle dabbing of tissue paper.
Acclimatization
Subjects will need
to get acclimated under controlled temperature and humidity (22oC±5oC
and 50%± 30% Relative Humidity) for 15- 30 minutes prior to measurements.
Baseline
evaluations
Subjects
will be evaluated instrumentally and visually for change in skin conditions
from baseline.
Product
application
The IP will be
applied on the face, after having washed face with the provided cleanser for
the entire study course.
One pump of the
provided investigational product to be applied on face, twice daily (post
morning bath and 2 hours prior to bed time after having washed face with the
provided cleanser) for the entire study course.
Subjects will be requested to maintain a
diary to record daily product usage.
Post
treatment assessment
Subjects will be evaluated instrumentally and visually for change in
skin conditions from baseline immediately post first application, at weeks 2,
4, 6 and 8.
|