| CTRI Number |
CTRI/2022/05/042725 [Registered on: 23/05/2022] Trial Registered Prospectively |
| Last Modified On: |
20/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety & efficacy assessment of products on skin. |
|
Scientific Title of Study
|
To evaluate the moisturization effect of two skincare formulations – Cebhydra Cream (WWY0018) & Cebhydra Lotion (WWY0030) on healthy human female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD01-SN-MH22; Version: 01; Dated: 05/05/2022 |
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 |
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA
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 |
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| Mascot Spincontrol India Pvt. Ltd.
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Limited |
| Address |
Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
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 (Suburban) MAHARASHTRA 400013 India
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 inner forearms with corneometer reading of 30 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cebhydra Cream (WWY0018) |
Application is carried out once at site on the marked areas of 3x3 cm2 on the right inner forearms for the period of 24 hours |
| Intervention |
Cebhydra Lotion (WWY0030) |
Application is carried out once at site on the marked areas of 3x3 cm2 on the right inner forearms for the period of 24 hours |
| Comparator Agent |
Untreated site |
one site of 3x3 cm2 on the right inner forearm is served as untreated control site |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian female subjects
2. Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
3. Between 18 and 40 years of age.
4. Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar).
5. Having dry skin on inner forearms with corneometry reading of <30.
|
|
| ExclusionCriteria |
| Details |
1. For Female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2. Having started, changed or stopped a hormonal treatment (e.g., hormonal contraception, Hormonal Replacement Therapy, thyroid) in the past 3 months
3. Having taken an oral retinoid-based treatment in the past 6 months.
4. Having had a local retinoid-based treatment on the studied areas in the previous month.
5. Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week
6. Having applied a moisturizing product on the studied areas in the 5 days preceding the start of the study. (only hands cleaned with water is accepted)
7. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week
8. Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
9. Having practiced intensive sports during the day prior to the T0 measurements
10. Having wounds, Scars, sunburns, tattoos and piercing on test site.
11. Having applied another product than water on the studied areas in the morning of the T0 measurements
12. Having had an intensive UV exposition on the forearms (solariums, sun) during 5 days prior to T0 measurements.
13. Having used any skin care products as well as skin care cleansers such as bath/shower oils on the forearms during 5 days prior to T0 measurements.
14. Having hair on test site.
15. Refusing to follow the restrictions below during the study:
Do not take part in any family planning activities leading to pregnancy and breastfeeding , Do not take part in another study liable to interfere with this study , Do not take 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), During the study: Do not use other cosmetic products than the tested product to the studied areas., Do not have beauty treatment (e.g. scrub, manicure self-tanning product) , Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.), Do not drink/ eat caffeine-based products (coffee, cola, tea), alcohol, highly spiced food, nor smoke , Do not practice sport , Do not apply any product on inner forearms including water., Do not wipe their inner forearms., Do not wear jewels on the wrists, Do not have an intensive UV exposition on the inner forearms (solariums, sun).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent improvement in capacitance value i.e skin moisturization |
30 minutes, 2 hours, 4 hours, 6 hours, 8 hours & 24 hours after product application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percent reduction in transepidermal water loss (TEWL), Percent improvement in skin softness , safety of Product |
30 minutes, 2 hours, 4 hours, 6 hours, 8 hours & 24 hours after product application |
|
|
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)
|
27/05/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of this study is to evaluate the
moisturization effect of two skincare formulations – Cebhydra Cream (WWY0018)
& Cebhydra Lotion (WWY0030) on healthy human female subjects.
The
evaluation is performed using:
n
Subject
Self Evaluation (SSE) Questionnaire (Moisturization
Effect & Safety)
n
Subject
Self Evaluation (SSE) Questionnaire (Cosmetic Appeal)
n
Dermatological
Evaluation : Safety
n
Dermatological
Evaluation : Skin softness
n Corneometry
n Tewametry
Study Population : 33 female
subjects are selected for
the stud The subjects
selected for this study are healthy females, aged between 18 and 40 years, having dry skin
on inner forearms with corneometer reading of <30.
Study Duration :(Screening
period to Last-Patient-Out) (A+B+D): 37 days
Study Duration (First-Patient-In
to Last-Patient-Out) (B+D): 23 days
A
= Screening period
(Period for identification of eligible 33
subjects): 14 days
B
= Enrollment period (Period for conducting
baseline visits of 33 subjects): 21 days
C
= Run-in period:
Not applicable
D
= Treatment period per patient: 2 days
Study will be carried out on the randomized 3
sites of 3x3 cm2 marked areas on the right inner forearms; product A
and product B will be applied at two sites (one test product per site) and one
site will serve as untreated control. |