| CTRI Number |
CTRI/2022/01/039601 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
17/02/2023 |
| 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 test products on application in human volunteers. |
|
Scientific Title of Study
|
Skin Irritation Test (Patch Test in Humans) IS 4011:2018
Guidelines |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/124/1221/STU Version No.: 1 of 28th December 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 |
Shiv Krupa, S.R.A. CHS Ltd, 1st Floor, Panam Park, Off Sahar Road, Vile Parle East
Mumbai
MAHARASHTRA
400 057
India |
| Phone |
02266758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Kaveri |
| Designation |
Marketing Director |
| Affiliation |
Beiersdorf India Pvt. Ltd. |
| Address |
07, 4th floor, B-wing, Art Guild House, Phoenix Market City,
LBS Marg, Kurla West
Mumbai
MAHARASHTRA
400 070
India |
| Phone |
40476900 |
| Fax |
|
| Email |
Pooja.Kaveri@Beiersdorf.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Kaveri |
| Designation |
Marketing Director |
| Affiliation |
Beiersdorf India Pvt. Ltd. |
| Address |
07, 4th floor, B-wing, Art Guild House, Phoenix Market City,
LBS Marg, Kurla West
Mumbai
MAHARASHTRA
400 070
India |
| Phone |
40476900 |
| Fax |
|
| Email |
Pooja.Kaveri@Beiersdorf.com |
|
|
Source of Monetary or Material Support
|
| Beiersdorf India Pvt. Ltd.
07, 4th floor, B-wing, Art Guild House, Phoenix Market City,
LBS Marg, Kurla (West), Mumbai- 400 070 |
|
|
Primary Sponsor
|
| Name |
Beiersdorf India Pvt |
| Address |
07, 4th floor, B-wing, Art Guild House, Phoenix Market City, LBS Marg, Kurla (West), Mumbai- 400 070, |
| Type of Sponsor |
Other [Cosmetic] |
|
|
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
MAHARASHTRA |
02266758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indepedent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with healthy skin will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ankle Binder Support |
Test product will be cut into 1.5 X 1.5 cm2 and applied with occlusion using micropore
tape, on arm/back of participants. |
| Intervention |
Back Lumbo Sacral Support |
Test product will be cut into 1.5 X 1.5 cm2 and applied with occlusion using micropore tape, on arm/back of participants |
| Comparator Agent |
Isotonic Saline- Negative
Control |
Filter papers dipped in 0.9% isotonic saline solution-negative control, (to contain approximately 0.04 ml of solutions) will be
filled in wells (with wells measuring 1 cm2 area) of patch chambers and applied
occlusively at test site(arm/back).
Patches will be secured using micropore tape. Duration of occlusion will be 24 hours |
| Intervention |
Knee Support |
Test product will be cut into 1.5 X 1.5 cm2 and applied with occlusion using micropore tape, on arm/back of participants. |
| Intervention |
Neck Cervical Support |
Test product will be cut into 1.5 X 1.5 cm2 and applied with occlusion using micropore
tape, on arm/back of participants. |
| Comparator Agent |
Sodium Lauryl sulphate-
Positive Control |
Filter papers dipped in 1% w/w
SLS solution-positive control, (to contain approximately 0.04 ml of solutions) will be filled in wells (with wells measuring 1 cm2 area) of patch chambers and applied occlusively at test site(arm/back). Patches will be secured using micropore tape. Duration of occlusion will be 24 hours |
| Intervention |
Tennis Elbow Support with
Protection Pad |
Test product will be cut into 1.5 X 1.5 cm2 and applied with occlusion using micropore
tape, on arm/back of participants. |
| Intervention |
Wrist Support |
Test product will be cut into 1.5 X 1.5 cm2 and applied with occlusion using micropore
tape, on arm/back of participants. |
|
|
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. Photo type III to V.
3. Having apparently healthy skin on test area.
4. For whom the Investigator considers that the compliance will be correct.
Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
5. Having signed a Consent Form.
6. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the study.
7. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna...), during the course of the study.
8. Should be able to read and write (in English, Hindi or local language).
9. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy (by history) and lactating women.
2. Scars, excessive terminal hair or tattoo on the studied area.
3. Dermatological infection/pathology on the level of studied area.
4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
5. Any clinically significant systemic or cutaneous disease, which may interfere with study
procedures.
6. Chronic illness which may influence the outcome of the study.
7. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the study (presently or in the past 1 month).
8. 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 skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2022 |
| Date of Study Completion (India) |
07/02/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This test is performed to assess the dermal safety of test products involved in the study. It is a technique used to determine the potential of specific substances to cause irritancy of the skin. Irritants are substances that damage the skin by direct toxic action. The damage will depend upon the nature of the irritant, its concentration, and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), oedema (swelling), vesiculation and finally to an intense suppurative reaction without the involvement of immune system. In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed under a constant artificial daylight source and the marked site is scored post 24 hours after the removal of the patches. Reactions such as erythema, dryness and wrinkling are scored on a 0 – 4-point scale and oedema is scored on another 0 – 4-point scale (Draize scale).
Results: The study was completed with 52 volunteers and no adverse events. The products were well tolerated. |