| CTRI Number |
CTRI/2022/04/041938 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of skincare formulation |
|
Scientific Title of Study
|
Evaluation of irritation potential of Skin care formulations on healthy human subjects of varied skin type |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q28-KD-MH22; Version No.: 01; Dated: 06/04/2022 |
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India Mumbai MAHARASHTRA 400013 India |
|
|
Primary Sponsor
|
| Name |
Kama Ayurveda Pvt Ltd |
| Address |
3 K Commercial Circle, Jungpura Extension, New Delhi – 110014 |
| 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. |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel 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 |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Varied skin Types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amarrupa Face Oil –
Puig Aroma (AHI-125) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Mridul Soap Free Face
Cleanser (B20211210) |
1:2 solution of the investigational product will be prepared in distilled water. 40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 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 T0 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Nimrah Anti Acne Face
Pack (A17721) |
1:2 solution of the investigational product will be prepared in distilled water. 40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Comparator Agent |
Positive Control (1% w/w Sodium Lauryl Sulphate) |
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 T0 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Sugandhadi oil – PUIG Aroma (AHL-103) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 visit. This is a single application and the occluded patch is removed after 24 hours |
| Intervention |
Urjasara Face oil - Puig Aroma
(UFOLT01-BIB-103) |
40 microliters of product is dispensed on aluminium finn chambers and then be taped onto the back of subjects at T0 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) Healthy Human Subjects
2) Skin should be healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
3) Subjects willing to come for regular follow up and ready to follow instructions during the study period.
4) Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination)
|
|
| ExclusionCriteria |
| Details |
For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, Poriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis |
|
|
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 |
Baseline,0 hrs,24 hrs and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2022 |
| Date of Study Completion (India) |
26/04/2022 |
| 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
|
Single Application, occlusive, Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin. Objective: To evaluate the irritation potential on healthy human subjects of hair Care Formulation. Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) T1(Patch removal, Evaluation of test sites by Dermatologist T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases) Population: 24 healthy subjects (12 males + 12 females) with varied skin types. The distribution of volunteers as per skin type will be as follows:
Oily skin – 3 Females + 3 Males, Normal skin – 3 Females + 3 Males, Dry skin – 3 Females + 3 Males, Combination skin – 3 Females + 3 Males The test area is checked for erythema and oedema caused due to the products and compared with positive control. |