| CTRI Number |
CTRI/2021/11/038298 [Registered on: 26/11/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the safety of a test product using the patch test technique |
|
Scientific Title of Study
|
Evaluation of Skin Safety of a test product for Primary Skin Irritation Using Skin Irritation Test (Patch Test in Humans) IS 4011:2018 Guidelines. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/094/1021/STU Version No.: 1 of 28 th October 2021 |
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 |
C.L.A.I.M.S. Pvt. Ltd.
Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No 103, 1st Floor,
Panam Park, Off Sahar Road, Vile Parle East, Mumbai
Mumbai
MAHARASHTRA
400 057
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Abhinav Gupta |
| Designation |
Senior Director – NPD & Operations |
| Affiliation |
Mosaic Wellness Private Limited |
| Address |
Mosaic Wellness Private Limited
701, 7 th Floor, Skyline Icon, Andheri Kurla Road, Chimatpada, Marol, Andheri (East),
Mumbai
Mumbai
MAHARASHTRA
400059
India |
| Phone |
8879972102 |
| Fax |
|
| Email |
abhinav@mosaicwellness.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Abhinav Gupta |
| Designation |
Senior Director – NPD & Operations |
| Affiliation |
Mosaic Wellness Private Limited |
| Address |
Mosaic Wellness Private Limited
701, 7 th Floor, Skyline Icon, Andheri Kurla Road, Chimatpada, Marol, Andheri (East),
Mumbai
Mumbai
MAHARASHTRA
400059
India |
| Phone |
8879972102 |
| Fax |
|
| Email |
abhinav@mosaicwellness.in |
|
|
Source of Monetary or Material Support
|
| Mosaic Wellness Private Limited
701, 7 th Floor, Skyline Icon, Andheri Kurla Road, Chimatpada, Marol, Andheri (East),Mumbai 400059 |
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Private Limited |
| Address |
701, 7 th Floor, Skyline Icon, Andheri Kurla Road, Chimatpada, Marol, Andheri (East), |
| Type of Sponsor |
Other [Health and wellness Institution] |
|
|
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. |
Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No: 103, 1st Floor,
Panam Park, Off Sahar Road, Vile Parle East, Mumbai 400 057,
Mumbai
MAHARASHTRA |
02266758851
rsjdrs@gmail.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 |
Healthy human volunteers will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Isotonic Saline- Negative Control |
Filter papers dipped in negative control-0.9% isotonic saline solution (to
contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers
and applied on back/ upper arm of participants. Then it will be occluded.
Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Comparator Agent |
1% Sodium Lauryl sulphate- Positive Control |
Filter papers dipped in positive
control 1% Sodium lauryl sulphate (to
contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers
and applied on back/ upper arm of participants. Then it will be occluded.
Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Intervention |
Bodywise 1% Ketoconazole Shampoo |
Filter papers dipped in 8% w/w solution of the shampoo prepared in distilled water (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on back/ upper arm of participants. Then it will be occluded.
Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and women (preferably equal number of males and females) between 18
and 65 years.
2. Fitzpatrick skin type III to IV.
3. Having apparently healthy skin on test area.
4. Willingness to discontinue the use of cleansing and/or cosmetic products in the application
areas during the course of the trial
5. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
6. Willing to give written informed consent to participate in the trial after informing all
information concerning the trial procedures and trial objectives.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the trial.
8. Willingness to avoid water contact (swimming) or activity which cause sweating (exercise, sauna…), during the course of the trial.
9. Should be able to read and write (in English, Hindi, or local language). |
|
| ExclusionCriteria |
| Details |
1.Pregnancy (by history) and lactating women.
2.Scars, excessive terminal hair, or tattoo on the studied area.
3. A participant who the Investigator feels will not be compliant with trial requirements
4.Dermatological infection/pathology on the level of studied area.
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
6. Any clinically significant systemic or cutaneous disease, which may interfere with trial
procedures.
7. Chronic illness which may influence the outcome of the trial.
8. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the trial (presently or in the past 1 month).
9. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of cutaneous tolerance of skin reactions (erythema, oedema, dryness, scaling
wrinkling), using Draize scale. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2021 |
| Date of Study Completion (India) |
25/12/2021 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The test product, Be Bodywise 1% Ketoconazole Dandruff Shampoo-B. No: BKS-01 was dermatologically tested and found to be “Non-Irritant†based on IS 4011 :2018,Methods of Test for safety evaluation of cosmetics -Third Revision. |