| CTRI Number |
CTRI/2024/02/062963 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin care formulations] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy assessment of skin care product |
|
Scientific Title of Study
|
To evaluate and compare the in-vivo safety and efficacy of three skin care formulations versus Untreated control in terms of the moisturization effect on healthy human subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD02-DX-JR24; Version: Final 01;01/02/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal 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 |
Principal 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
|
| Dabur India Ltd.
Dabur Research & Development Centre,
22, Site IV,
Sahibabad,
Ghaziabad-201 010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd. |
| Address |
Dabur Research & Development Centre, 22, Site IV, Sahibabad, Ghaziabad-201 010 |
| 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 4 randomized sites three for test products and one randomized site will serve as untreated control site. Application is carried out once for period of 72 hours |
| Intervention |
Dabur Gulabari Moisturizing Body lotion (BK3078) |
Application to be carried out on the 4 randomized sites three for test products and one randomized site will serve as untreated control site. Application is carried out once for period of 72 hours |
| Intervention |
Dabur Gulabari Moisturizing Cold Cream (BK3111 |
Application to be carried out on the 4 randomized sites three for test products and one randomized site will serve as untreated control site. Application is carried out once for period of 72 hours |
| Intervention |
New Dabur Gulabari Moisturizing Body lotion (BK3016) |
Application to be carried out on the 4 randomized sites three for test products and one randomized site will serve as untreated control site. Application is carried out once for period of 72 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 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 |
| Improvement in skin Moisturization |
Baseline, 30 minutes, 48 hours and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
25/02/2024 |
| 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 in-vivo safety and efficacy of three Skin Care Formulations versus Untreated control in terms of the Moisturizing Effect on healthy human subjects The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Corneometry POPULATION: 33 (16/17 females & 17/16 males) subjects are selected for this study. The subjects selected for this study are healthy females and males aged between 18 and 65 years, having dry skin on forearms. STUDY DURATION: 72 Hours following the application of the product. |