| CTRI Number |
CTRI/2022/12/047808 [Registered on: 01/12/2022] Trial Registered Prospectively |
| Last Modified On: |
|
| 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
|
Safety and efficacy assessment of Product on skin |
|
Scientific Title of Study
|
PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot)& radiant skin and skin brightness on healthy male & female subjects. SECONDARY OBJECTIVE To evaluate the in-vivo safety and efficacy in terms of signs of ageing: minimize fine lines, smooth skin texture, reducing dark circles and improvement in skin hydration on healthy male & female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF09-KD-NR22; Version: Final 01; Dated: 14/11/2022 |
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 West, Mumbai. MAHARASHTRA 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 West, Mumbai. MAHARASHTRA 400013 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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. MAHARASHTRA 400013 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 (Suburban) MAHARASHTRA 400013 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 |
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 |
Volunteers with dull skin, pigmentary spots, crow’s feet wrinkles, uneven skin tone & visible under
eye dark circle and presenting Fitzpatrick skin type III to V |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KMB FACE OIL
(KAKKBT – 001) |
Approximately 4-5 drops of the Product will be applied once in a day on whole face. for period of 28 days. |
| Comparator Agent |
Nil |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 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 55 years of age.
4. Skin is healthy on the studied anatomic unit
5. Presenting Fitzpatrick skin type III to V, with chromameter (ITA value) reading between -30 & 41 on cheek bones.
6. Having dull skin and uneven skin tone
7. Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas.
8. Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas.
9. Having visible under eye dark circle.
|
|
| 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 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:
-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)
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 her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
16. Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
17. Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
18. Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
19. 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
20. 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
21. Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
22. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
23. For males, having not shaved their beard 24 hours prior to the day of measurement.
24. 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 effheect 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.
- For males, having not shaved their beard 24 hours prior to the day of measurement.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Even skin tone,
reduction in pigmentation (dark spot), radiant skin and skin brightness |
Baseline, 14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ageing: minimize fine
lines, smooth skin texture, reducing dark circles and improvement in skin hydration |
Baseline, 14 days and 28 days |
|
|
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)
|
02/12/2022 |
| 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="2"
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: PRIMARY OBJECTIVE
To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone,
reduction in pigmentation (dark spot), radiant skin and skin brightness on healthy male & female
subjects. SECONDARY OBJECTIVE
To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine
lines, smooth skin texture, reducing dark Duration of study: 28 days study Kinetics: T0, T+14 days and T+28 days Population: 36 (18 Females & 18 Males) volunteers The evaluation is performed using: 1. Subject’s Self Evaluation, 2. Dermatological Evaluation: Cosmetic Acceptability, 3. Dermatological Evaluation: Efficacy 4. Chromametry 5. Corneometry 6. CLBT (Color, Luminosity, Brightness, Transparency) 7. Cutometry 8. Tewametry 9. Sebumetry 10. Mexametry 11. Illustrative photographs of whole face & ¾ th face under diffused light |