| CTRI Number |
CTRI/2023/02/050012 [Registered on: 23/02/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| 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
|
Assessment of safety & Efficacy of cosmetic product |
|
Scientific Title of Study
|
The objective of this study will be to evaluate the efficacy and safety of a skin care formulation in terms of improvement in skin brightness
on healthy human female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF05-TI-DR22 ; Version: 01; Dated: 27/01/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal 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 |
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
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
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 pigmentory dark spots on face |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Turmerisa Double-Turmeric Facial Essence |
Product will be applied on the whole face and neck, twice a day application in morning and at night before
going to bed on the whole face & neck for the period of 60 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 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) Having pigmentory dark spots on face
|
|
| 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. 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 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) 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)
16) Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
17) Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
18) Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
19) Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
20) Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…)
21) 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
22) 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.
23) Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
24) 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
25) Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
26) 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 |
Baseline, 15 days, 28 days, 45 days & 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in skin smoothness, skin softness, skin moisturization, skin firmness, reduction in pigmentory dark spots |
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)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2023 |
| Date of Study Completion (India) |
12/05/2023 |
| 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 on healthy human female subjects.
Product : Turmerisa Double-Turmeric Facial Essence: Product A The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Safety, Dermatological Evaluation: Efficacy, Chromametry (L* parameter for skin brightness & DE parameter for skin even tone), Corneometry (Capacitance parameter Skin Moisturization), Cutometry (R0 parameter for skin firmness) Total duration of the study: 60 days following the first application of product. Kinetics: T0, T+15 days, T+28 days, T+45 days & T+60 days Product application : Twice a day, in morning and at night before going to bed on the whole face & neck for the period of 60 days Number of volunteers: 36 female subjects |