| CTRI Number |
CTRI/2022/09/045182 [Registered on: 02/09/2022] Trial Registered Prospectively |
| Last Modified On: |
02/09/2022 |
| 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
|
Primary objective: To assess the in-vivo safety and efficacy of Skin care formulation in terms
of reduction in Crow’s feet wrinkles, dark circles & improvement in skin moisturization & skin
firmness in comparison with untreated area on healthy male & female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QY01-KD-AT22,Version: Final 01; Dated: 18/08/2022 |
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai 400013, MAHARASHTRA 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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai 400013, MAHARASHTRA India
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai 400013, MAHARASHTRA India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| MASCOT-SPINCONTROL India Pvt. Ltd. , 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai 400013, MAHARASHTRA India |
|
|
Primary Sponsor
|
| Name |
Kama Ayurveda Pvt Ltd |
| Address |
3 K Commercial Circle, Jungpura Extension, New Delhi – 110014 |
| 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. MAHARASHTRA 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 |
healthy subjects having mild to moderate crow’s feet wrinkles, having visible dark circles & visible
fine lines. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serum |
Product to be applied around the one eye(right or left) once at night and other eye is kept as untreated control. Product will be applied for 28 days. |
| Comparator Agent |
Untreated control area |
Product is applied around one eye and other eye area is kept as untreated control area for all the 28 days of study. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Indian Male and 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 35 and 50 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria
5.Having mild to moderate crows feet wrinkles according to the Bazins atlas. [using Page n° 40 & 41 of Skin Ageing Atlas (Scale: 0 to 6)].
6.Having visible under eye dark circles.
7.Having under eye wrinkles of grade 2 to 4 according to the Basins atlas [ using Page n° 46 and 47 under eye Wrinkles of Skin Ageing Atlas (Scale 0 to 8)]
8.Having visible Fine lines.
|
|
| ExclusionCriteria |
| Details |
1 For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give 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 a progressive asthma.
6 Being epileptic.
7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8 Having cutaneous hypersensitivity
9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10 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)
11 Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
14 Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted)
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). Do not change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. Do not have 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)
16 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
17 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
18 Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
19 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
20 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…)
21 Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or having applied self-tanning products in the week preceding the start of the study
22 Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
23 Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
24 Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months
25 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
26 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 start a medicinal treatment which could lead to hyper pigmentation - Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) - Do not consume caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements - Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self tanning products - Do not use products or techniques or surgery with a depigmenting / whitening action - Do not expose herself to the sun by respecting a strict photo-protection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety, Reduction in Crow’s feet wrinkles, dark circles & improvement in skin moisturization & skin
firmness |
Baseline, Day 1, day 3 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIl |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/09/2022 |
| 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="3"
Days="0" |
|
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 will be to assess the safety and efficacy of Skin care formulation in terms
of reduction in Crow’s feet wrinkles, dark circles & improvement in skin moisturization & skin
firmness in comparison with untreated area on healthy male & female subjects Duration of study: 28 days study Kinetics: T0, T+30 minutes, T+1 day, T+3 days and T+28 days Population: 40 (20 Females & 20 Males) volunteers The evaluation is performed using: 1
Subject Self Evaluation
2
Dermatological evaluation: Cosmetic
Acceptability
3
Ophthalmological Evaluation: Safety
4
Dermatological evaluation: Efficacy
5
Cutometry
6
Corneometry
7
Tewametry
8
Analysis of the skin color through cross
polarized light
|