| CTRI Number |
CTRI/2024/12/077872 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hydration study |
|
Scientific Title of Study
|
A randomized, Single-blinded, controlled study to evaluate the effect of Test
Product on skin hydration, skin barrier, Luminance for a period of 9 days. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/ITHS/2024-05 version 1.0 dated 15 Nov 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Department of Skin Sciences
Room no 1, 324 Second Floor,
1st Main Road
Cambridge Layout
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Department of Skin Sciences
Room no 1, 324 Second Floor,
1st Main Road
Cambridge Layout
Ulsoor
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Department of Skin Sciences
Room no 1, 324 Second Floor,
1st Main Road
Cambridge Layout
Ulsoor
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
|
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] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Department of Skin Sciences,
Room no:1, 324, Second Floor
1st Main Road
Cambridge layout
Ulsoor
Bangalore
KARNATAKA |
8040917253
mukta.sachdev@msclinical.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JHB-78 |
The test product will be applied by the study personnel at all the study visits (day 1 to day 8) and the assessment will carried out after 30 minutes of test product application.
a.The Test product (bar) is moistened with water and is rotated 5 times
in the palm to generate foam.
b. The bar is rubbed directly on the demarcated assessment site 5
times, following a rectangular pattern to cover the entire assessment
site.
c. The bar is rotated 5 times between 2 palms with a little water to aid
generate dense foam.
d. The dense foam is transferred onto the assessment site and rubbed
across the assessment site by rotation motion 5 times.
e. Foam is retained on the application/assessment site for 90 seconds.
f. Foam is rinsed with clean water for 20 seconds, ensuring complete
removal of foam from the site.
|
| Intervention |
Moisturiser Premix
FMP-82 |
About 125µl of the Test Moisturizer Premix will be dispensed and spread
all over evenly on the designated test site on day 9.
The Moisturizer pre-mix is rubbed following 20 clockwise and 20
anti-clockwise circular motions to aid absorption in the skin.
Assessments will be carried out 30 mins post moisturizer mix application. |
| Intervention |
UDS-35 |
The test product will be applied by the study personnel at all the study visits (day 1 to day 8) and the assessment will carried out after 30 minutes of test product application.
a.The Test product (bar) is moistened with water and is rotated 5 times
in the palm to generate foam.
b. The bar is rubbed directly on the demarcated assessment site 5
times, following a rectangular pattern to cover the entire assessment
site.
c. The bar is rotated 5 times between 2 palms with a little water to aid
generate dense foam.
d. The dense foam is transferred onto the assessment site and rubbed
across the assessment site by rotation motion 5 times.
e. Foam is retained on the application/assessment site for 90 seconds.
f. Foam is rinsed with clean water for 20 seconds, ensuring complete
removal of foam from the site. |
| Comparator Agent |
Untreated control |
No test product will be applied on the site demarcated as an untreated control site and remain as untreated. |
| Comparator Agent |
Water treated control |
No test product will be applied on the site demarcated as a water-treated control site. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects of Indian origin, in the age group of 19-45 years (both ages
inclusive).
2. Subject having Normal to dry skin.
3. Subjects with no cuts, abrasions, wounds, injuries, allergies, tattoos, scars,
henna or any other developments/artifacts forearms that can impact the
measurements.
4. Subjects willing to give a voluntary written informed consent and agree to
come for regular follow-up visits as per the scheduled time.
5. Subjects willing to abide by and comply with the study protocol.
6. Subjects willing to not apply any other products on the test site for the
duration of the study. |
|
| ExclusionCriteria |
| Details |
A known history or present condition of allergic response to any cosmetic
or fragrance-containing products.
2. Subjects under chronic medication (e.g. aspirin-based products, anti-
inflammatories, anti-histamines, corticotherapy, etc.) that might influence
the outcome of the study or under Systemic treatment or having Chronic
illness (diabetes mellitus, hypertension, liver disease, or history of
alcoholism, HIV, hepatitis, etc.,) which may modify the cutaneous state on
the day of inclusion or in the previous 30 days.
3. Subjects with wounds, sunburn, scars, tattoos, piercings or a history of
intense sun exposure/phototoxicity/allergy at the skin test site(s).
4. Subjects with application of ointments, creams etc. for antibacterial, anti-
allergic or immunosuppressive treatment of the skin at the test site(s)
5. Subjects who are pregnant or nursing (as confirmed by Urine pregnancy
test for the determination of Pregnancy). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in skin hydration, skin barrier properties and skin Luminance/radiance/ brightness in comparison to
the Baseline, Reference product and Controls. |
Approximately 9 days for each subject excluding screening. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
20/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is a randomized, Single-blinded, controlled study aimed to evaluate the efficacy of test products in improving skin hydration, skin barrier function and its maintenance, and improved skin radiance/luminance compared to baseline at defined time points following the application of test products on the forearm. Subjects will be screened based on inclusion/exclusion criteria and enrolled after providing informed consent. At Visit 1, baseline instrumental and dermatological assessments (hydration, barrier function, dryness, smoothness, and safety) will be conducted after acclimatization. The test, reference, water, and untreated control products will be applied. Visits 2 to 8 will involve product applications. On visit 8, the test products will be applied and the assessments for hydration, barrier function, dryness, smoothness, and safety will be carried out after 30 minutes. On Visit 9, a moisturizer pre-mix will be applied, and efficacy will be assessed at baseline, 30 minutes post-product application and 30 minutes post rinse off of the pre-mix. study duration: approximately 9 days for each subject excluding screening visit. |