| CTRI Number |
CTRI/2023/05/053276 [Registered on: 30/05/2023] 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 safety of test product in Humans |
|
Scientific Title of Study
|
Evaluation of Skin Safety of a test product using 24 Hours Patch Test on Adult Healthy
Human Participants with Normal Skin. IS 4011:2018 Guidelines. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/017/0423/STU Version No.: 1 of 02nd May 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 |
4th floor, B wing, Modi House,
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
MAHARASHTRA
400058
India |
| Phone |
|
| 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 |
4th floor, B wing, Modi House,
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
MAHARASHTRA
400058
India |
| Phone |
|
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
C.L.A.I.M.S. Pvt. Ltd. |
| Address |
4th floor, B wing, Modi House,
C-10, Dalia Industrial Estate,
New Link Road, Andheri (W)
Mumbai
MAHARASHTRA
400058
India |
| Phone |
|
| Fax |
|
| Email |
preetha@claimsclinical.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.), |
| 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. |
Shiv Krupa, S.R.A. CHS Ltd, C Wing, Room No: 103, 1st Floor, 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/2023/014 |
Filter papers dipped in ‘DRDC/2023/014’ (to contain approximately 0.04 ml of
test product) will be filled in well of patch chamber and applied semi-occlusively on back/upper arm of participant.
Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Comparator Agent |
Negative Control - 0.9% isotonic saline solution |
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 test sites on back/upper arm of participant. Then it will be occluded. Patches will be secured using micropore tape. Duration of occlusion will be 24 hours. |
| Intervention |
Positive control - 1% w/w SLS solution |
Filter papers dipped in positive control - 1% w/w SLS solution (to contain approximately 0.04 ml of solutions) will be filled in different wells of patch chambers and applied on test sites on back/upper arm of participant. 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 (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 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 of skin reactions |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/06/2023 |
| Date of Study Completion (India) |
09/06/2023 |
| 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)
|
Patch test - This test is performed to assess the dermal safety of test product involved in the trial. 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).
Result: The study was completed and there were no adverse events that occured during the course of the study. |