| CTRI Number |
CTRI/2023/03/050912 [Registered on: 21/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| 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
|
Primary Objective: To evaluate the efficacy Skin Care Formulation in terms of Skin Brightening Effect on healthy female subjects.
Secondary Objective: To evaluate the in-vivo safety and efficacy of a skin care formulation in terms of Improvement in Skin Water Barrier Function and in Skin Smoothness on healthy female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF04-DT-FR22; Version: Final 01; Dated: 06/03/2023 |
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
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 MAHARASHTRA 400013 India |
|
|
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] |
|
|
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 having varied skin
types i.e.Dry,oily,combination and normal skin.
Volunteers having having wheatish to dark complexion. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Not Applicable |
| Intervention |
Sunscreen Gel : Product A |
Take 0.5 gm of the test product will be applied once in the morning and re-apply after 4 hrs on the whole face and neck for the period of 28 days. |
|
|
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.Between 18 and 50 years of age
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
Specific criteria
5.44 Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily,
Normal, Dry and Combination)+13 sensitive skin (declared through lactic acid sting test).
6.Having wheatish to dark complexion.
|
|
| 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 signing the consent form
3.Taking part in another study liable to interfere with this study
4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less
than 6 months)
6.Having a progressive asthma (either under treatment or last fit in the last 2 years)
7.Being epileptic
8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6
months)
9Having cutaneous hypersensitivity
10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic
products or food products or to latex
11.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)
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) on the studied areas the first day of the
study (only face cleaned with water is accepted).
15.Do not take part in any family planning activities leading to pregnancy and breastfeeding
16.Do not take part in another study liable to interfere with this study
17.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)
18.Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
19.During the study: Do not use other cosmetic products than the tested products to the studied areas (only usual cleanser/soap is accepted)
20.The day of the measurements: No test product must be used (only face cleaned with water is
accepted)
21.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone
Replacement Therapy) in the past 3 months.
22.Having started, changed or stopped her tobacco consumption (for smokers consuming more than
10 cigarettes per day) in the previous 6 months
23.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn,
amiodarone, metals, minocycline…) in the previous 6 months
24.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta￾
carotene…)
25.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
26.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
27.Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks
preceding the start of the study.
28.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
29.Having a suntanned skin on the studied areas which could interfere with the evaluations of the
study.
30.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 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 action.
- Do not practice water activities (swimming pool, sauna, hammam, balneotherapy).
- 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 |
| Skin Brightening Effect. |
Baseline,30 minutes ,7 days,14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Skin Water Barrier Function and Skin Smoothness. |
Baseline,30 minutes,7 days,14 days and 28 days |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2023 |
| 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
|
PRIMARY OBJECTIVE: The objective of this study will be to assess the efficacy of Skin Care Formulation in terms of Skin Brightening Effect on healthy female subjects coded SECONDARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of a skin care formulation in terms of Improvement in Skin Water Barrier Function and in Skin Smoothness on healthy female subjects coded Duration of study: 28 days study Kinetics: T0,T+30 minutes, T+7 days,T+14 days & T+28 days Population: 56 (44 Varied skin volunteers +12 sensitive skin) volunteers The evaluation is performed using: Subject Self Evaluation Dermatological Evaluation: Cosmetic Acceptability Chromametry Tewametry Illustrative photographs of face under diffused light |