| CTRI Number |
CTRI/2022/08/044896 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of safety and efficacy of skin care formulation |
|
Scientific Title of Study
|
PRIMARY OBJECTIVE: To assess the efficacy of skin care regime in terms of Skin Brightening Effect on healthy female subjects
SECONDARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of a skin care regime in terms of Improvement in Skin Water Barrier Function and in Skin Smoothness on healthy female subjects
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF03-DT-FR22; Version: 01; Dated: 25/07/2022 |
Protocol Number |
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|
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 (Suburban) 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. Mumbai (Suburban) 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. Mumbai (Suburban) 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. Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. Mumbai (Suburban) MAHARASHTRA 400013 India |
|
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Primary Sponsor
|
| Name |
DPKA Universal Consumer Ventures Private Limited |
| Address |
3002, 30th Floor, Beau Monde, Tower B, Prabhadevi Road, Prabhadevi, Mumbai – 400025. |
| Type of Sponsor |
Other [FMCG] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
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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 |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
43 normal skin volunteers and 13 sensitive skin and having wheatish to dark complexion & visible dry skin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Standard Face Wash |
In study duration of 28 days face has to be cleaned with sponsor provided standard face wash. |
| Intervention |
Standard Moisturizer |
In study duration of 28 days approx. 0.5 to 1 gm of sponsor provided standard moisturizer to be used. |
| Intervention |
Sunscreen Drops |
Approximately 8-10 drops of the product to be applied on whole face The test product to be applied thrice in a day in the morning, afternoon & evening (every 4hours while in the sun) for the period of 28 days. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian / Asian 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….) Specific criteria
4. 43 normal skin volunteers +13 sensitive skin (declared through lactic acid sting test).
5. Having wheatish to dark complexion.
6. Having visible dry skin.
|
|
| ExclusionCriteria |
| Details |
1 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 (either under treatment or last fit in the last 2 years)
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 undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
12 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
13 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)
14 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 her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. -During the study: Do not use other cosmetic products or skin care products other than the tested products to the studied areas. (only standard facewash is accepted). The day of the measurements: No test product must be used (only face cleaned with water is accepted) Specific criteria
15 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months.
16 Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
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 action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
22 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
23 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
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 use products or techniques or surgery with a depigmenting - Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) - Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self tanning products action. - Do not swim in artificial water bodies (pools, hot tubs etc.…) - Do not expose herself to the sun by respecting a strict photo-protection |
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| skin brightening, skin safety |
Baseline, 30 min after product application, 7 days, 14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Skin
Water Barrier Function and in Skin Smoothness |
Baseline, 30 min after product application, 7 days, 14 days and 28 days |
|
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Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2022 |
| 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 |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
PRIMARY OBJECTIVE: The objective of this study will be to assess the
efficacy of skin care regime in terms of Skin Brightening Effect on healthy
female subjects.
SECONDARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of a
skin care regime in terms of Improvement in Skin Water Barrier Function and in
Skin Smoothness on healthy human subjects.
Test Product: SUNSCREEN DROPS: Product
A
The evaluation is performed
using: Subject’s Self Evaluation, Dermatological Evaluation: Safety,
Dermatological Evaluation: Efficacy, Chromametry, Tewametry, Illustrative
photographs of face under diffused light.
Total duration of the study: 28 days
following the first application of product.
Kinetics: T0, T+30 minutes after
product application, T+7 days, T+14 days and T+28 days
Number of volunteers: 56 (43 normal
skin volunteers +13 sensitive skin)
|