| CTRI Number |
CTRI/2022/07/044281 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FMCG] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of safety of cosmetic product |
|
Scientific Title of Study
|
The objective of this study is to evaluate the irritation potential on healthy human subjects of Skin
Care Formulation coded |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q16-TI-FR22; Version: 01; Dated: 27/05/2022 |
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 |
Mr 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 |
Having apparently healthy skin on Test area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ambhring Age
Embrace Revitalizer
(T6-0221)
|
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Balaayah Black Gram
Bright Body Booster
(6A/RD/12/21) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Chakramarda Tail
(TLS/CMT/22/01) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Charmaroganashaka
Tail (TLS/CRNT/22/01) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Dashmoola Tail
(TLS/DST/22/01) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Madhyama Narayana
Tail (TLS/MNT/22/01) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Mamitra oil (RD-028
(B)) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Mehfranz Eternally
Fragrant Body
Massage Oil (P-425) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Murchhita Erand Tail
(TLS/MET/22/01) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Navikara Renewal
Fluid (0120) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Comparator Agent |
Negative Control
(0.9% Isotonic saline
solution) |
40 microliters of 0.9% Isotonic saline solution is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Comparator Agent |
Positive Control
(1% w/w SLS) |
40 microliters of 1% w/w Sodium Lauryl Sulphate is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rujarelief Foot & Leg
Soother Oil (0122) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Shankhpushpi Tail
(TLS/SPT/22/01) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Turmerisa DoubleTurmeric Facial
Essence (0321) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T1 visit. This is a single application and the occluded patch is removed after 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Female and male Asian Indian subjects.
2. Healthy Human 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. Photo type III to V.
5. Having apparently healthy skin on Test area.
6. For whom the Investigator considers that the compliance will be correct.
7. Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
8. Having signed a consent form.
9. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
10. Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise sauna…) during the course of the study.
11. Should be able to read and write in English Hindi or local language.
12. Having valid proof of identity and age.
|
|
| ExclusionCriteria |
| Details |
1. For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give his/her assent by not signing the consent form
3. Taking part in another study liable to interfere with this study
4. Being diabetic.
5. Being asthmatic.
6. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
7. Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
8. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
9. Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
10. Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
11. The day of the patch application: no cosmetic product must be used (test site clean with water only).
12. Scars excessive terminal hair or tattoo on the studied area.
13. Henna tattoo anywhere on the body (in case of studies involving hair dyes).
14. Dermatological infection pathology on the level of studied area.
15. Hypersensitivity & allergy to any cosmetic product raw material or hair dye.
16. Any clinical significant systematic or cutaneous disease which may interfere with the study treatment or procedure.
17. Chronic illness which may influence the outcome of this study.
18. Subjects on any medical treatment either systematic or topical which may interfere with the performance of the study treatment presently or in the past one month.
19. Subject in an exclusion. Or participating in another food cosmetic or therapeutic trial.
20. Refusing to follow the restrictions below during the study: - For female: Do not become pregnant nor breastfeed - 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, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). - Do not change his/her cosmetic habit so yeah s apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological safety / Irritation potential on skin |
24 hrs after patch removal and T9 days
(1 week
after 0 hour
of patch
removal) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2022 |
| Date of Study Completion (India) |
04/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
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
|
The objective of this study is to evaluate
the irritation potential on healthy human subjects of Skin Care Formulations
Product : Chakramarda Tail
(TLS/CMT/22/01): Product A, Charmaroganashaka Tail (TLS/CRNT/22/01): Product B,
Dashmoola Tail (TLS/DST/22/01): Product C, Madhyama Narayana Tail
(TLS/MNT/22/01): Product D Shankhpushpi Tail (TLS/SPT/22/01): Product E,
Murchhita Erand Tail (TLS/MET/22/01): Product F & Mamitra oil (RD-028 (B)):
Product G Rujarelief Foot & Leg Soother Oil (0122) : Product H, Balaayah
Black Gram Bright Body Booster (6A/RD/12/21): Product I, Navikara Renewal Fluid
(0120): Product J, Ambhring Age Embrace Revitalizer (T6-0221): Product K,
Mehfranz Eternally Fragrant Body Massage Oil (P-425): Product L, Turmerisa
Double-Turmeric Facial Essence (0321): Product M
The evaluation is performed
using: Dermatological Evaluation: Single
Application Patch Test Method
Total duration
of the study: 8 days following the first application of product.
Kinetics: T1 = (Patch application), T2 day =
(0hour after the patch removal), T3 days = (24 hours after patch removal), T9*
days = (T+1 week after 0 hour of patch removal)
Number of
volunteers: Twenty-four (24) subjects(12 female and 12 male) |