| CTRI Number |
CTRI/2023/10/058731 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the irritant and allergic potential of test products in Men and Women. |
|
Scientific Title of Study
|
Skin irritation and skin sensitization potential (Allergenicity) of 4 test products using Human
Repeat Insult Patch Test (HRIPT) IS 4011:2018 Guidelines. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/113/0923/STU Version No: 1 of 27th September 2023 |
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 |
5th Floor, 27 MIDC
Commercial Premises, 17th Road, MIDC Andheri
East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
5th Floor, 27 MIDC
Commercial Premises, 17th Road, MIDC Andheri
East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasi Bhushan Vedula |
| Designation |
Senior Manager – Medical Affairs & Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Plot No.22, Site IV, Sahibabad-201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
1203378638 |
| Fax |
|
| Email |
sasibhushan.vedula@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur Research and Development Centre, Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), India. |
|
|
Primary Sponsor
|
| Name |
Dabur Research and Development Centre |
| Address |
Plot No.22, Site IV, Sahibabad-201010, Ghaziabad (U.P.), India. |
| Type of Sponsor |
Other [Ayurvedic and Natural Healthcare ] |
|
|
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. |
Room No: 103, 1st Floor, C wing Shiv Krupa, S.R.A. CHS Ltd, Panam Park, Off Sahar Road, Vile Parle East
Mumbai
MAHARASHTRA |
66758851
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 |
| Intervention |
DRDC/2023/032 |
Filter papers dipped in diluted ‘DRDC/2023/032’ (to contain approximately
0.04 ml of solution), will be filled in well of patch chambers and will be applied occlusively on the upper arm/back of each participant
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 |
DRDC/2023/033 |
Filter papers dipped in diluted ‘DRDC/2023/033’ (to contain approximately 0.04 ml of solution), will be filled in well of patch chambers and will be applied occlusively on the upper arm/back of each participant 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 |
DRDC/2023/034 |
Approximately 0.04 gm. Product will be filled in wells of patch
chambers applied occlusively on the upper arm/back of each participant. 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 |
DRDC/AY/8010 |
-Filter papers dipped in the solutions to contain approximately 0.04 ml
of solutions will be filled in patch chambers and applied occlusively on upper arm/back of each participant. 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. |
| 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. |
|
|
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, with 50 participants having sensitive
skin as determined by lactic acid sting test.
2. Fitzpatrick skin type III to V.
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 (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna...), during the course of the trial.
9. Should be able to read and write (in English, Hindi, or local language).
10. Ready to wear loose cotton clothes.
11. Having valid proof of identity and age.
12. Subject having not participated in another similar cosmetic or therapeutic trial in the past
one month. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy (by UPT) 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 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 |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "209"
Final Enrollment numbers achieved (India)="209" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/10/2023 |
| Date of Study Completion (India) |
20/01/2024 |
| 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
|
N/A |
|
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.
Result: The study was completed and there were no adverse events that occured during the course of the study. |