| CTRI Number |
CTRI/2022/12/048219 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
09/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the safety of Primary Irritation Patch Test test product in healthy volunteers |
Scientific Title of Study
Modification(s)
|
“Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of application on healthy human all skin typesâ€.
|
| Trial Acronym |
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|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/064-Version-1.0-dated:25-NOV-2022 |
Protocol Number |
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep K Alva |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
TrialGuna Private Limited # 467,1st Main, 4th Cross, Royal
County Layout, JP Nagar 8th Phase,2nd block, Bangalore-560083
Bangalore
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
sandyalva78@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Meena Dalal |
| Designation |
Director |
| Affiliation |
TrialGuna Private Limited |
| Address |
TrialGuna Private Limited # 467,1st Main, 4th Cross, Royal
County Layout, JP Nagar 8th Phase,2nd block, Bangalore-560083
Bangalore
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
Director |
| Affiliation |
TrialGuna Private Limited |
| Address |
TrialGuna Private Limited # 467,1st Main, 4th Cross, Royal
County Layout, JP Nagar 8th Phase,2nd block, Bangalore-560083
Bangalore
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Vasu Health Care 967/4, Near ERDA, Makapura GIDC, Makapura, Vadodara, Gujarat 390010
|
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|
Primary Sponsor
|
| Name |
Vasu Health Care |
| Address |
967/4, Near ERDA, Makapura GIDC, Makapura, Vadodara, Gujarat 390010
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashwini N J |
TrialGuna |
2nd floor, Room No 1,# 467,1st Main, 4th Cross, Royal
County Layout, JP Nagar 8th Phase,2nd block, Bangalore-560083
Bangalore
KARNATAKA |
6361137954
ashwini.nj@trialguna.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: R&G Face pack, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: od, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure.
2.Healthy Men & women volunteers are chosen in ratio of 1:1 aged > 35 and < 60 years.
3.Having healthy skin on test area as assessed by dermatological examination and don’t have history of allergy.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant/nursing mothers.
2.Scars, excessive terminal hair, or tattoos on the studied area.
3.Dermatological infection/pathology on level of studied area.
4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
5.Chronic illness which may influence the outcome of the study.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
2.1. Primary End Point: Number ofsubjects that showed no significant irritation. Score of less than or equal to 2 on the Draize scale.
|
Baseline,Day1, Day 2, Day 3, Day 7
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Secondary Outcome
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|
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Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/12/2022 |
| Date of Study Completion (India) |
27/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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|
Brief Summary
|
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 35 years to 65 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).
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