| CTRI Number |
CTRI/2018/07/014741 [Registered on: 05/07/2018] Trial Registered Prospectively |
| Last Modified On: |
11/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To determine whether the test product is causing irritation or allergy in human participants after repeated applications of patch |
|
Scientific Title of Study
|
Human Repeat Insult Patch Test (HRIPT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/030/0618/STU - Version 1 of 20th June 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT. LTD |
| Address |
4th Floor, B wing, Modi House,
C-10, Dalia Industrial Estate, New Link Road,
Andheri (W), Mumbai - 400058
Mumbai
MAHARASHTRA
Dr Rajiv Joshi
India |
| Phone |
2266758851 |
| Fax |
|
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nikunj Bali |
| Designation |
Manager-New Product Development |
| Affiliation |
Amishi Consumer Technologies Private Limited, |
| Address |
Amishi Consumer Technologies Private Limited,
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi, India - 110013
New Delhi
DELHI
110013
India |
| Phone |
08800712526 |
| Fax |
|
| Email |
nikunj.bali@themomsco.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nikunj Bali |
| Designation |
Manager-New Product Development |
| Affiliation |
Amishi Consumer Technologies Private Limited, |
| Address |
Amishi Consumer Technologies Private Limited,
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi, India - 110013
New Delhi
DELHI
110013
India |
| Phone |
08800712526 |
| Fax |
|
| Email |
nikunj.bali@themomsco.com |
|
|
Source of Monetary or Material Support
|
| Amishi Consumer Technologies Private Limited,
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi,
India - 110013 |
|
|
Primary Sponsor
|
| Name |
Amishi Consumer Technologies Private Limited |
| Address |
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi,
India - 110013 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajiv Joshi |
C.L.A.I.M.S. PVT.LTD |
4th Floor, B wing, Modi House,
C-10, Dalia Industrial Estate, New Link Road,
Andheri (W), Mumbai - 400058
Mumbai
MAHARASHTRA |
2266758851
rsjdr@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having apparently healthy skin on studied area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% isotonic solution of saline |
0.04 ml of product will be applied and occluded |
| Intervention |
Alcohol Free Hand Sanitizer |
0.04 ml of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Baby Cream |
0.04 gm of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Bottom Spray |
0.04 ml of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Foaming Hand Wash |
0.04 ml of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Mosquito Repellent |
0.04 gm of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Soothing Relief Lotion |
0.04 gm of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Soothing Relief Wash |
0.04 ml of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Sunscreen Lotion |
0.04 gm of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Tummy Relief Oil |
0.04 ml of product will be applied and occluded |
| Intervention |
The Moms Co. Natural Water Wipes |
Small piece of wipes will be applied and occluded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Having apparently healthy skin on studied area.
For whom the Investigator considers that the compliance will be correct.
Willingness to avoid water contact or activity which cause sweating, during the course of the study.
|
|
| ExclusionCriteria |
| Details |
People who have a job involving water contact or a job which causes perspiration.
Pregnancy and lactating women.
Hypersensitivity allergy antecedent to any cosmetic product in general or raw material by history.
Participants with any skin condition that may cause interference with interpretation of the reactions or participants with past or present history of a photosensitive dermatosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of cutaneous tolerance by dermatological scoring |
Induction Phase: Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 15, Visit 17, Visit 19.
Challenge Phase: Visit 22, Visit 23 and Visit 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "230"
Final Enrollment numbers achieved (India)="230" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/07/2018 |
| Date of Study Completion (India) |
08/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
HRIPT was conducted
for 10 Products. The following products · The
Moms Co. Natural Soothing Relief Lotion - Batch No.: R107290618 · The
Moms Co. Natural Soothing Relief Wash - Batch No.: R108290618 · The
Moms Co. Natural Baby Cream - Batch
No.: R109290618 · The
Moms Co. Natural Tummy Relief Oil - Batch No.: KR-MC-P38 · The
Moms Co. Natural Foaming Hand Wash - Batch No.: R11290618 · The
Moms Co. Natural Water Wipes -
Batch No.: 8318 · The
Moms Co. Mineral Based Sunscreen - Batch No.: R106290618 ·
The Moms Co. Alcohol Free Hand Sanitizer - Batch No.: KR-MC-P39
were found to be Non-Irritant and likely to be hypoallergenic.
The following products · The
Moms Co. Natural Mosquito Repellent - Batch No.: KR-MC-P47 · The
Moms Co. Natural Baby Bottom Wash - Batch No.: R110290618
were found to be Non-Irritant but likely to be allergenic. |