| CTRI Number |
CTRI/2022/02/040126 [Registered on: 09/02/2022] Trial Registered Prospectively |
| Last Modified On: |
17/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Orthopaedic soft goods] |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the irritancy and allergic potential of a test product in Men and Women. |
|
Scientific Title of Study
|
Human Repeat Insult Patch Test (HRIPT)IS 4011:2018 Guidelines. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/131/0122/STU Version No: 1 of 11th January 2022 |
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, C Wing, Room No: 103, 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 |
| Comparator Agent |
Isotonic Saline -
Negative Control |
0.04ml of Isotonic Saline solution will be applied on the volunteers back on alternate days and scoring done on alternate days. Duration of occlusion will be 24 hours. A total of
9 applications will be carried out. The participants will be asked to return after a rest period of 10-14
days for Challenge phase. Patches will be applied on the first visit and removed after 24 hours.
Scoring will be carried out after 48 hours, 72 hours, 96 hours. |
| Intervention |
Knee Support |
1.5 x 1.5 cm2 of the test product will be applied on the volunteers back alternate days and scoring done on alternate days. Duration of occlusion will be 24 hours. A total of
9 applications will be carried out. The participants will be asked to return after a rest period of 10-14
days for Challenge phase. Patches will be applied on the first visit and removed after 24 hours.
Scoring will be carried out after 48 hours, 72 hours, 96 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary men and women 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.
5. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
6. Having signed a Consent Form.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the study.
8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna...), during the course of the study.
9. Should be able to read and write (in English, Hindi or local language).
10. Having any 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 cutaneous tolerance by dermatological scoring. |
Visit 1: ICD and inclusion/ exclusion.
Induction Phase: Patch application on Visit 1 (V1, V3,V5, V7, V9, V11, V13, V15, V17).
Patch will be removed on Visit 2 (V2, V4, V6, V8, V10, V12,V14, V16, V18).
Patch area will be clinically examined, graded and scored on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19)
Challenge Phase: Patch application will be on naïve sites on the back on V20;
patch will be removed at V21 (24 hours).Scoring on V22 (48 hours), V23 (72 hours). V24 (96 hours). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "212"
Final Enrollment numbers achieved (India)="212" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2022 |
| Date of Study Completion (India) |
27/01/2023 |
| 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)
|
Topical exposure to chemicals can lead to adverse skin effects or skin intolerances. While some chemicals will only trigger an irritant response after repeated exposure of the same skin area, other chemicals will even after a one-time exposure cause irritation. HRIPT is a standard test; usually performed to check the tolerance of a product on skin after repeated application of those products on the same site. Sensitization is the process by which a person becomes, over time, increasingly allergic to a substance through repeated exposure to that substance. It is very different from irritation because it involves immune response, the reaction becomes worse with repeated exposure, and it is usually specific to individuals. The HRIPT consists of 2 phases, possibly 3. Phase I is the Induction Phase where product is applied to the skin 9 times over duration of 3 weeks. This is a followed by rest period of 10- 14 days after which the skin is exposed to the product again in Phase II or the Elicitation Phase. A response in Phase II is usually allergic in nature. In some cases when reactions at challenge are weak or do not follow a consistent pattern, it may be necessary to conduct additional studies on a participant to determine if the responses are indicative of allergy. This is Phase III of the study- Rechallenge Phase. A Rechallenge may also be performed to verify that the response is persistent.
Results: The study was completed with 212 volunteers and no adverse events. The products were Non Irritant and Hypo-allergenic. |