| CTRI Number |
CTRI/2022/06/043478 [Registered on: 24/06/2022] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy assessment of Product on skin |
|
Scientific Title of Study
|
To evaluate the invivo safety and efficacy of the skin care formulation in terms of sweat resistance on healthy human subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XF01-SN-MY22; Version: Final 01; Dated: 25/05/2022 |
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 |
Kohinoor 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 |
Kohinoor 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 |
Kohinoor 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. |
Kohinnor Estate, 3rd Floor, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
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 |
being able to produce at least 100 mg of sweat |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Photostable Emulgel New formulation |
0.5gm of Product will be applied on randomised half face and other half face will served as control. Application will be done once at site for period of 2 days. |
| Comparator Agent |
Untreated half face |
The test product will be applied on randomized half face and the other untreated halve is served as control. No product to be used on site for period of 2 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian male & 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. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4. Being able to produce at least 100 mg of sweat and whose left versus right half face sweat is more or less the same
5. Having shaved beard two days before study visit.
|
|
| ExclusionCriteria |
| Details |
1. For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2. Having refused to give his/her assent by not 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 sensitive or dry skin & acne prone skin.
6. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
7. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
8. 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).
9. Having cutaneous hypersensitivity.
10. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
12. 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)
13. Refusing to follow the restrictions below during the study:For Females: 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); Do not change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit; Do not have sensitive or dry skin & acne prone skin.; During the study: Do not use other cosmetic products than the tested products to the studied areas.; The day of the measurements: No test product must be used (only face cleaned with water is accepted); The day of the measurements: Do not apply hair oil.
14. Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
15. Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
16. Not having shaved beard two days before study visit.
17. Having applied oil one day prior study visit.
18. Refusing to follow the restrictions below during the study:Do not start, change or stop a hormonal treatment (hormonal contraception, Hormone Replacement Therapy); Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) ; Do not practice water activities (swimming pool, sauna, hammam); Do not practice sport the day of the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sweat resistance, safety |
Day 1: 30 minutes after product application, Day 2: 30 minutes after product application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
27/06/2022 |
| 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
|
Objective: The objective of this study is to evaluate the in-vivo safety and efficacy
of the skin care formulation in terms of sweat resistance on healthy human
subjects for test product
Kinetics: Day 1 (T0 &
T+30 minutes after product application) and Day 2 (T0 & T+30 minutes after
product application)
Population: 33 (17 Female & 16 Male) subjects
The
evaluation is performed using:
- Subject Self Evaluation (SSE)
- Dermatological Evaluation:
Cosmetic Acceptability
- Tewametry
- Sweat Patch Test
Duration: 2 days following the first application of the
product.
|