| CTRI Number |
CTRI/2022/12/048271 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| 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 & Efficacy assessment of skin care formulation |
|
Scientific Title of Study
|
The objective of this study will be to evaluate efficacy of skin care formulation in terms of reduction in appearance of fine lines and wrinkles, density of dark spots, improvement in skin moisturization, skin firmness on healthy female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-RF03-TI-AT22; Version: 01; Dated: 06/10/2022 |
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 applicble |
|
|
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 |
The subjects selected for this study are healthy females aged between 35 and 55 years, having crows feet wrinkles & fine lines of grade 2-4 and dark spots & loose on face, neck and upper arms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BALAAYAH BLACK GRAM BRIGHT BODY BOOSTER(T6-0422):Product A |
Product will be applied on the whole face, neck and upper arms, once in a day in morning for the period of 60 days |
| Comparator Agent |
NONE |
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)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
4)Having crows feet wrinkles, fine lines of grade 2 - 4 & Dark spots
5)Having loose skin(face, Neck and upper arms) |
|
| ExclusionCriteria |
| Details |
1 Female subjects who are pregnant (determined by Urine pregnancy test) 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 Having known allergy to any of the Ingredient of the Test Product
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 consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
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) or skin care product on the studied areas on the 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 consume any caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements, 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 usual cleanser/soap is accepted), The day of the measurements : No test product must be used (only test site cleaned with water is accepted)
17 Having started, changed or stopped a Hormone Replacement Therapy in the past 6 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 taken a Dehydroepiandrosterone based treatment in the previous 6 months.
20 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.
21 Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months.
22 Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous year.
23 Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years.
24 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
25 Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
26 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.
27 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
28 Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week.
29 Having practiced sport, the day of start 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 use products or techniques or surgery with an anti-wrinkles/ anti ageing action /firming action and depigmenting/ whitening action, 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 practice sport the days of study, Do not expose herself 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 |
| Reduction in appearance of fine lines & wrinkles, Deansity of dark spots, improvement in skin moisturization,Skin firmness |
Baseline, 15 Days, 28 Days,45 Days, 60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skin safety, Improvement in skin water barrier, reduction in circumference of upper arm |
Baseline, 15 Days, 28 Days,45 Days, 60 Days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2022 |
| Date of Study Completion (India) |
10/03/2023 |
| 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
The objective
of this study will be to evaluate efficacy of skin care
formulation in terms of reduction in appearance of fine lines and
wrinkles, density of dark spots, improvement in skin moisturization, skin
firmness on healthy female subjects.
SECONDARY OBJECTIVE
Secondary objective is to
evaluate the in-vivo safety & efficacy of a skin care formulation in terms
of Safety and improvement in skin water barrier & reduction in
circumference of upper arm.
Product : BALAAYAH
BLACK GRAM BRIGHT BODY BOOSTER (T6-0422) : Product A
The evaluation is performed
using : Subject’s Self Evaluation, Dermatological Evaluation:
Safety, Dermatological Evaluation: Efficacy, Measurement of circumference of
upper arm, Tewametry( skin water barrier), Cutometry (R0 parameter for skin firmness),
Corneometry (Capacitance parameter Skin Moisturization), Illustrative Images of
the whole face & ¾ th face under diffuse light
Total duration of the
study: 60 days following the first application of product.
Kinetics: T0, T+15 days,
T+28 days, T+45 days and T+60 days
Product application :
Once in a day application on whole face, neck and upper arms for the period of
60 days
Number of
volunteers: 36 female subjects |