| CTRI Number |
CTRI/2022/12/048214 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Skin care formulations] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment ofsafety & Efficacy of cosmetic product |
|
Scientific Title of Study
|
The objective of this study will be to evaluate efficacy of a skin care formulation in terms of improvement in skin
brightness and skin even tone on healthy female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF03-TI-AT22 ; Version: 01; Dated: 29/09/2022 |
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. Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Satyendra Kumar |
| Designation |
Sr. Manager - Clinical Research |
| Affiliation |
Transformative Learning Solution Pvt. Ltd. |
| Address |
Transformative Learning Solution Pvt. Ltd. 3rd Floor, Veritas Tower, Sector 53, Gurugram, Haryana-122002
Gurgaon
HARYANA
122002
India |
| Phone |
9891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.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
|
| Transformative Learning Solution Pvt Ltd, 3rd Floor, Veritas Tower, Sector 53,Gurugram, Haryana- 122002 |
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solution Pvt Ltd |
| Address |
3rd Floor, Veritas Tower, Sector 53,Gurugram, Haryana- 122002. |
| 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. 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 |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy females, aged between 35 and 55 years old,having crow’s feet wrinkles & fine lines on the face, having uneven skin tone, having dark spot (age spot) and at least one spot of 3.5 mm diameter |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manjish Glow Night -
Time Elixir : Product A |
Product will be applied on the whole face, once in a day in night before sleeping for the period of 28 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 or 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)
4) Having uneven skin tone
5) Having wrinkles on Crows feet area with a grade of 2 (mild) to 4 (moderate) according to the
Bazin Atlas
6) Having dark spot (age spot) and at least one spot of 3.5mm diameter |
|
| 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)
9 Having 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 Having known allergy to any of the Ingredient of the Test Product.
12 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)
13 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
14 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
15 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)
16 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 than the tested products to the studied areas (only usual cleanser/soap is accepted) ; The day of the measurements: No test product must be used (only face cleaned with water is accepted)
17 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
18 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
19 Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
20 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
21 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…)
22 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
23 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.
24 Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
25 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
26 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
27 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 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 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in skin
brightness and skin even tone |
baseline, 8 hours after product application, 7 days, 21 days,45 days, 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
reduction in appearance of
wrinkles & fine lines, improvement in skin moisturization and skin firmness, reduction in the density
of dark spots (age spots) |
baseline, 8 hours after product application, 7 days, 21 days,45 days, 60 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/12/2022 |
| Date of Study Completion (India) |
13/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
PRIMARY
OBJECTIVE To evaluate the efficacy and safety of a skin care formulation in
terms of improvement in skin brightness and skin even tone on healthy female
subjects.
SECONDARY
OBJECTIVE To evaluate the efficacy and safety of a skin care formulation in
terms of reduction in appearance of wrinkles & fine lines, improvement in
skin moisturization and skin firmness, reduction in the density of dark spots
(age spots) on healthy female subjects.
Product : Manjish Glow Night - Time Elixir (Sample-D) : Product A
The evaluation is performed using: Subject’s Self
Evaluation, Dermatological Evaluation: Safety, Dermatological Evaluation:
Efficacy, Chromametry (L* and ITA° parameter for skin brightness
& Delta E parameter for skin even tone), Corneometry (Capacitance
parameter Skin Moisturization), Cutometry (R0 parameter for skin firmness), Illustrative
Images of the whole face and 3/4th face under diffuse light
Total duration of the study: 60 days following the first
application of product.
Kinetics: T0, T+8 hours after product application, T+7
days, T+21 days, T+45 days and T+60 days
Product application : Once in a day at night application on whole face for the period of 28
days
Number of volunteers: 36 female subjects |