| CTRI Number |
CTRI/2022/06/043010 [Registered on: 03/06/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2023 |
| 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) IS 4011:2018 Guidelines. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/013/0422/STU Version No.: 1 of 21 st April 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 |
Room No:103, C Wing, 1st Floor, Shiv Krupa, S.R.A. CHS Ltd, 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 |
Dr Mukesh Gabhane |
| Designation |
Senior Medical Advisor, |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East)
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
9619101705 |
| Fax |
|
| Email |
mukesh.gabhane@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Thavkar |
| Designation |
General Manager – Medical Affairs |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East)
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
|
| Fax |
|
| Email |
amit.thavkar@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd. |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd |
| Address |
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East),
Mumbai, Maharashtra (India) – 400 063 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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. |
C Wing, Room No:103, 1st Floor,Shiv Krupa, S.R.A. CHS Ltd, 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 |
| Independent 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 |
Filter papers dipped in negative control - 0.9% isotonic saline solution (to contain
approximately 0.04 ml of solution) will be filled in different well of patch chambers and applied
on test sites on back of participants. Then it will be occluded.
Each participant will be applied with a patch of the test product and a patch of the negative control.
Patches will be secured using micropore tape. Duration of occlusion will be 24 hours.
A total of 9 applications will be carried out in Induction phase. The participants will be asked to return after a rest period of 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 |
Photostable new formulation-
OCTCB |
Approximately 0.04 g of test product will be filled in well of patch chamber and applied
occlusively on back of participant. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours.
A total of 9 applications will
be carried out in Induction phase. The participants will be asked to return after a rest period of 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 healthy 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 etc), during the course of the study.
9. Should be able to read and write (in English, Hindi or local language).
10. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy (by UPT) 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 (Draize scale for Induction scoring and ICDRG scale for Challenge scoring). |
Induction Phase:
- Patch application on Visit V1, V3, V5, V7, V9, V11, V13, V15 and V17.
- Patch removal on Visit 2 (V2, V4, V6, V8, V10, V12, V14, V16 and V18).
- Scoring on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19)
Rest Phase: 10 – 14 days
Challenge Phase: Patch application will be on naïve sites on the arm/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="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "213"
Final Enrollment numbers achieved (India)="213" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/06/2022 |
| Date of Study Completion (India) |
02/09/2023 |
| 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 at 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, over the time becomes allergic to a substance through repeated exposure to that substance. It is very different from irritation because it involves immune response. Reaction becomes worse with repeated exposure, and it is usually specific to individuals. The HRIPT consists of 3 phases -Induction Phase, Rest Phase, Challenge Phase. 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 Phase II which is the rest phase of about 14 days after which the skin is exposed to the product again in Phase III or the Elicitation/Challenge Phase. A response in Phase III is usually allergic in nature.
Result: The study was completed with 213 completed cases and no adverse events were reported. |