| CTRI Number |
CTRI/2023/03/050222 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmaceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy assessment of Product on skin |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy and safety of a skin care regime in terms of anti-aging effects i.e., reduction in fine lines and wrinkles, reduction in density of dark spots (age spots), improvement in skin moisturization, improvement in skin brightening and improvement in skin firmness on healthy female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-RF01-RT-DR22; Version: Final 01; Dated: 25/01/2023 |
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.
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.
Mumbai
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.
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 |
BRIGHT LIFECARE PVT. LTD. |
| Address |
The Presidency, Tower B, Second Floor, 46/4,
M G ROAD, SECTOR-14,
Opp. Girls Collage,
GURUGRAM-122001. |
| 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 crows feet wrinkles of grade 2-4 and dark spots (Age Spot) density of 2 and above. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HKVitals Collagen Face Cleanser:Product A |
This is the first product of test regime. Take 0.5gm quantity of test product and massage all over the face. Rinse with water and pat dry. Apply test product twice a day at morning & evening on whole face for the period of 84 days. |
| Intervention |
HKVitals Collagen Face Serum:Product B |
This is the second product of test regime. Take 4-5 drops of test product and apply on whole face. Spread the test product in outward direction. Apply test product twice a day at morning & evening on whole face for the period of 84 days. |
| Intervention |
HKVitals Collagen Moisturizer:Product C |
This is the third product of test regime. Take approx. 1 gm quantity of test product and apply dot wise on the whole face. Spread the test product in outward direction. Apply test product twice a day at morning & evening on whole face for the period of 84 days. |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 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 35 and 55 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) |
|
| ExclusionCriteria |
| Details |
1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2.Having refused to give her/his assent by 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.Being asthmatic.
6. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
7.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).
8.Having cutaneous hypersensitivity.
9.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11.Having changed his/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 his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
- Do not practice water activities (swimming pool, sauna, hammam, balneotherapy)
- During the study: Do not use other cosmetic products than the tested products to the studied areas. Do not use hair oil
- The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted)
14.Having started, changed or stopped a Hormone Replacement Therapy in the past 6 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 taken a Dehydroepiandrosterone based treatment in the previous 6 months.
17.Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid….) in the 2 weeks preceding the start of the study.
18.Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months.
19. Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous year.
20. Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years.
21.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
22. Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
23. 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.
24.Having consumed caffeine-based products (coffee, cola, tea …), alcohol, and highly spiced foods and/or smoked in the two hours preceding the measurements.
25. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
26.Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week.
27. Having practiced sport, the day of start of the study.
28.Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
29. 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 DHEA-based treatment
- Do not use products or techniques or surgery with an anti eye bags and / or anti dark circle and / or anti wrinkle action
- Do not expose himself/herself to the sun with the intention to sunbathe (activities outside which do not last too much time are authorized)
- Do not start an oral or local retinoid-based treatment
- Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self-tanning products
- Do not practice water activities (swimming pool, sauna, hammam, balneotherapy ...)
- Do not consume caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods nor smoke in the two hours preceding the measurements each day of study
- Do not practice sport the days of study.
- Do not expose yourself 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 |
| Reduction in fine lines and wrinkles, reduction in density of dark spots (age spots), improvement in skin moisturization, improvement in skin brightening and improvement in skin firmness |
Baseline, 28 days, 56 days & 84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2023 |
| Date of Study Completion (India) |
28/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 To evaluate the in-vivo efficacy and safety of a skin care regime in terms of anti-aging effects i.e., reduction in fine lines and wrinkles, reduction in density of dark spots (age spots), improvement in skin moisturization, improvement in skin brightening and improvement in skin firmness on healthy female subjects Duration of study: 84 days study Kinetics: T0, T+28 days , T+56 days & T+84 days Population: 36 Female volunteers The evaluation is performed using: - Subject Self Evaluation - Dermatological Evaluation: Cosmetic Acceptability - Dermatological Evaluation: Efficacy - Chromametry - Corneometry - Cutometry - Illustrative Images of the whole face under diffuse light Product application : All the three test products are part of test regime, Modalities of application for Product A: Wet your face with water. Take 0.5gm quantity of test product and massage all over the face avoiding eye area. Rinse thoroughly with water and pat dry. Modalities of application for Product B: Take 4-5 drops of test product and apply on whole face. Gently spread the test product in outward direction. Ensure that you don’t rub the product into your skin.
Modalities of application for Product C: Take approx. 1 gm quantity of test product and apply dot wise on the whole face. Gently spread the test product using only fingers in outward direction. Ensure that you don’t rub the product into your skin. |