| CTRI Number |
CTRI/2023/12/060868 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| 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 and compare the safety and efficacy of skin care formulation in terms of moisturization and Skin Barrier Function (trans epidermal water loss) versus untreated control on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD01-UL-NR23; Version: Final 01;21/11/2023 |
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 RD 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 RD 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 dry skin on forearms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Application to be carried out on the 2 randomized sites one for test product and one randomized site will serve as untreated control site. Application is carried out once for period of 100 hours |
| Intervention |
Moisturizer |
Application to be carried out on the 2 randomized sites one for test product and one randomized site will serve as untreated control site. Application is carried out once for period of 100 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
2)Subject having dry skin with corneometer reading less than 30 on forearms
|
|
| ExclusionCriteria |
| Details |
1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.Having refused to give her assent by signing the consent form.
2)Taking part in another study liable to interfere with this study.
3)Being known diabetic case
4)Known asthma case
5)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
6)Being known thyroid case
7)Being epileptic.
8)Following a chronic medicinal treatment comprising any of the following product: aspirin-based product, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol)
9)Known case of hypersensitivity.
10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic product.
11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
12)Having changed their cosmetic habits except those required by the protocol 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 48 hours prior study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Moisturization and Skin Barrier Function (trans epidermal water loss) |
Baseline, 2 hours, 24 hours, 48 hours, 100 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
01/01/2024 |
| 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="0"
Days="15" |
|
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 and compare
the safety and efficacy of skin care formulation in terms of moisturization and
Skin Barrier Function (trans epidermal water loss) versus untreted control on
healthy human subjects for product coded:
The evaluation is performed using: Subject Self Evaluation
(SSE), Dermatological Evaluation: Cosmetic Acceptability, Corneometry,
Tewametry
POPULATION: 33 (17/16 females & 16/17 males) subjects
will be selected for this study.
The subjects selected for this study are healthy females and
males aged between 18 and 65 years, having dry skin with corneometer reading
<30 on forearms.
STUDY DURATION: 100 Hours following the application of the
product. |