| CTRI Number |
CTRI/2023/12/060887 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin care formulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy check of skin care product |
|
Scientific Title of Study
|
To evaluate the in vivo safety and efficacy of a skin care formulations in terms of Skin Brightening, Skin Tone Evenness, and reduction in Acne PIH on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF01-UL-NR23; Version: Final 01;22/11/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Satiya Nutraceuticals Private Limited, Building No B3 2G, Asmeeta textile park MID, IND. Kalyan[1] bhiwandi road KON, Bhiwandi, Thane, Maharashtra, 421311 |
|
|
Primary Sponsor
|
| Name |
Satiya Nutraceuticals Private Limited |
| Address |
Building No B3 2G, Asmeeta textile park MID, IND. Kalyan[1] bhiwandi road KON, Bhiwandi, Thane, Maharashtra, 421311 |
| 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 |
| Dr Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA |
02243349191
raji@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having normal skin type with Dark Spots (Acne PIH) at least 1 spot, dull & uneven skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jamun Acne Marks Serum |
Approximately 4-5 drops of product to be applied on whole face, twice in a day morning and night for the period of 28 days |
| Comparator Agent |
NIL |
NA |
| Intervention |
Pineapple Depigmentation Dewy Serum |
Approximately 4-5 drops of product to be applied on whole face, twice in a day morning and night for the period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
2.Having normal skin type with Dark Spots (Acne PIH) at least 1 spot.
3.Having uneven skin tone.
4.Having dull skin.
|
|
| ExclusionCriteria |
| Details |
1)For female: Being pregnant or breastfeeding or having stopped to
breastfeed in the past three months.
2)Having refused to give her
assent by signing the consent form.
3)Taking part in another study liable to interfere with this study.
4)Being insulin-dependent diabetic or non insulin-dependent diabetic
with a recent therapy (less than 6 months)
5)Having a progressive asthma (either under treatment or last fit in
the last 2 years)
6)Being epileptic
7)Having non stabilized thyroid problems (requirement of a stabilized
treatment for at least 6 months)
8)Having cutaneous hypersensitivity
9)Having a diagnosed or highly probable allergy to one or several
compounds of the cosmetic products or food products or to latex
10) Following a chronic medicinal treatment comprising any of the
following products: aspirin-based products, anti-inflammatories,
anti-histamines, corticotherapy, taken by general or local routes (the
only medication permitted is paracetamol)
11)Having undergone a surgery requiring a general anaesthetic of
more than one hour in the past 6 months.
12)Having changed her cosmetic habits in the 14 days preceding the
start of the study on the studied anatomic unit
13)Having applied a cosmetic product (included make-up) on the
studied areas the first day of the study (only face cleaned with water
is accepted).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skin Brightening, Skin Tone Evenness, and reduction in Acne PIH |
Baseline, Day 7, Day14, Day28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
04/01/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OBJECTIVE
The objective of this study will be to evaluate the in vivo
safety and efficacy of a skin care formulations in terms of Skin Brightening,
Skin Tone Evenness, and reduction in Acne PIH on healthy human subjects.
The evaluation is performed using:Subject Self Evaluation, Dermatological
Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Mexametry,
Chromametry, Illustrative Images of the whole face & 3/4th face under
diffuse light
POPULATION: 72 (36 Male & 36 Female) subjects will be
selected for the study.
The subjects selected for this study are healthy male &
females, aged between 18 and 35 years old having normal skin type with Dark
Spots (Acne PIH) at least 1 spot, dull & uneven skin.
The study will be conducted in 2 groups.
Group A: This group will include 36 (18 male & 18 female)
subjects using Product A
Group B: This group will include 36 (18 male & 18 female)
subjects using Product B
STUDY DURATION: Duration: 28 days following the first
application of the product. |