| CTRI Number |
CTRI/2024/10/075749 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety Test for Product(DRDC/2024/038) Patch Test on Normal Skin |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Product(DRDC/2024/038) by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Normal Skin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFTCT284 Version 1.0 Dated 22 Aug 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
7078103723 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories Pvt Ltd |
| Address |
3RD Floor room 1, Clinical Research Dept, CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Srivastava |
| Designation |
Assistant Manager Medical Affairs and Clinical Research |
| Affiliation |
Dabur India Ltd |
| Address |
1st floor, Dabur Research and Development Centre, Dabur India limited, Plot No. 22, Site – IV, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9650535899 |
| Fax |
|
| Email |
ruchi.srivastava@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Ltd, 2nd Floor, Near Fema Pharma, sahibabad rd, Sahibabad Industrial Area Site 4-201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Plot No. 22, Site – IV, Sahibabad,
Ghaziabad, Uttar Pradesh – 201010 |
| Type of Sponsor |
Other [Ayurvedic and Natural Healthcare] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Robin Chugh |
CCFT laboratories |
AR multispecialty hospital and research center, 1st Floor room 3, Skin testing lab , CCFT laboratories, Delhi Road- 250002
Meerut
UTTAR PRADESH |
7078103723
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DRDC/2024/038 |
Neat, 0.04mg, single dose,
topical application, 24 hr |
| Comparator Agent |
Negative Control |
Neat, 0.9gm of Sodium Chloride
in 100ml of distilled water (0.9% w/v) , 0.04 mg, single dose, topical application, 24 hr |
| Comparator Agent |
Positive control |
1 gm of SLS in 100 mL of
distilled water (1 % w/v) , 0.04
mg, single dose, topical
application, 24 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Voluntary man or women (preferably equal number of males and females) between 18 and 65 years.
2. Fitzpatrick 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 excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), 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.
11. Subject having not participated in another trial in the past one month |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing mothers
2.Scars, excessive terminal hair or tattoo on the studied area
3.Henna tattoo anywhere on the body (in case of studies involving hair dyes)
4.Dermatological infection or pathology on the level of studied area
5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures
7.Chronic illness which may influence the outcome of the study
8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month)
9.Subject 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Skin Irritation Score-erythema & oedema |
Day 0, Day 2(24 hours post patch removal), Day 8 (1 week post patch removal) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
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
|
The below products would be tested as per the guideline IS4011 for dermal safety assessment. 1. DRDC/2024/038 The product will be tested for skin irritation on 24 human volunteers. Assessment would be done on day 0, day 2, with followup visit on day 8 for erythema and Oedema scoring. |