| CTRI Number |
CTRI/2022/02/039947 [Registered on: 02/02/2022] Trial Registered Prospectively |
| Last Modified On: |
05/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Other (Specify) [cosmetic product for safety evalution]] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety testing of cosmetic products by PIPT(Primary Irritation Patch Test) |
|
Scientific Title of Study
|
Evaluation of dermatological safety of test products by primary irritation patch test on healthy human volunteers of varied skin types |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL-CT-009-PIPT-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Aggarwal |
| Designation |
Principle investigator |
| Affiliation |
Auriga Research Pvt. Ltd. |
| Address |
Plot no-136, sec.-5,IMT Manesar, Gurgaon Haryana 122050 India
Gurgaon
HARYANA
122050
India |
| Phone |
0124006445 |
| Fax |
|
| Email |
dr.poojaggarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Karwa |
| Designation |
Head Clinical Trial and Pharmacovigilance |
| Affiliation |
Auriga Research Pvt. Ltd. |
| Address |
Plot no-136, sec.-5,IMT Manesar, Gurgaon Haryana 122050 India
Gurgaon
HARYANA
122050
India |
| Phone |
0124006445 |
| Fax |
|
| Email |
manojkarwa@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Purushotam |
| Designation |
Study Coordinator |
| Affiliation |
Auriga Research Pvt. Ltd. |
| Address |
Plot no-136, sec.-5,IMT Manesar, Gurgaon Haryana 122050 India
Gurgaon
HARYANA
122050
India |
| Phone |
0124006445 |
| Fax |
|
| Email |
purushotam@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Arbro Pharmaceutical Pvt Ltd
6/14 Kirti Nagar Industrial Area New Delhi 110015 India |
|
|
Primary Sponsor
|
| Name |
Arbro pharmaceutical Pvt Ltd |
| Address |
6/14 Kirti Nagar Industrial Area New Delhi 110015 India |
| 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 Pooja Aggarwal |
Auriga Research Pvt. Ltd. |
Plot no 136 sec. 05 IMT
Manesar Gurgaon HARYANA 122050
Gurgaon
HARYANA |
0124006445
dr.poojaggarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society For Ethical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult healthy subject (male and female) in the
age group of 18 years to 55 years (both
inclusive) will be selected |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Number of total products are 18
(Scrub, face wash, cleanser, Hair Oil, face mask, bathing bar) |
Approximately 40 μl of each
product are dispensed in the
aluminum chambers of the
patch and applied on the back
of volunteers the product is
applied for 24 hours under
occlusion |
| Comparator Agent |
Sodium Lauryl Sulphate (SLS)3% solution |
3% SLS Solution is applied for
24 hours under occlusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female subjects in the age group of 18-55 years(both age inclusive)
2. Subject is having valid proof of identity and age
3. Subjects with skin phototype III to V
4.Subject is having apparently healthy skin on test area
5.Subject representing normal, oily, dry and combination skin type in nearly equal ratio
6. Subject willing to give a voluntary written
informed consent
7. Subject willing to maintain the test patches
in designated positions for 24 Hours
8. Subject willing to come for regular follow up visits
9. Subject ready to follow instructions during the study period
10. Subject without any open wounds, cuts, abrasions, irritation symptoms |
|
| ExclusionCriteria |
| Details |
1. Subjects with Known hypersensitivity to any of the study products or constituents
2. Subjects having any significant pathology in the test area
3. Subjects with any kind of skin allergy, antecedents or cutaneous
disease which may
influence the study results
4. Subjects having topical or systemic treatment in last month prior to participation in the study and during the study that could interfere with the study treatments/ assessments
5. Athletes and subjects with history of excessive sweating
6. Subject is Pregnant or Lactating
7. Subject with any significant medical condition that would interfere with the participation in the trial
8. Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation
9. Subject is having Scars, excessive terminal hair or tattoo on the studied area |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety assessment of investigational products for
irritation potential using Draize scale after patch
removal at 0 hours(day 3),24 hours(day 4) and 7 days post
patch removal. |
Safety assessment of investigational products for
irritation potential using Draize scale after patch
removal at day 3, day 4 and 7 days post patch removal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2022 |
| Date of Study Completion (India) |
18/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
Objective: The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects. A primary irritation patch test is used widely for the evaluation of the safety of cosmetics in humans.
Sample Size: Twenty four (male and female, in a nearly equal ratio of 1:1) adult subjects in the age group of 18 years to 55 years (both inclusive)
Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance.
By this test, irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs and is done as per BIS standard (BIS4011:2018) |