| CTRI Number |
CTRI/2021/03/031792 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Irritation potential of
Meera Face Wash |
|
Scientific Title of Study
|
Evaluation of irritation potential of
Meera Face Wash (White Turmeric & Wild
Turmeric) through dermatological Evaluation
by single occlusive patch test on Healthy
adult human volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet,
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet,
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet,
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
|
Source of Monetary or Material Support
|
| CavinKare Private Limited
|
|
|
Primary Sponsor
|
| Name |
CavinKare Private Limited |
| Address |
Cavinville, 12, Cenotaph Rd, Rathna Nagar, Alwarpet, Chennai, Tamil Nadu 600018 |
| 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 Sakthi Balan |
Thirumalai Clinic and Raghavendra Diagnostic Centre |
Thirumalai Clinic, C/o. Raghavendra Diagnostic Centre, 153, Cuddalore main road, Mudaliarpet, Pondicherry – 605004
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ki3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin sensitivity testing |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Meera Face Wash |
Meera Face Wash (White turmeric & Wild Turmeric 0.09-0.11 %).
2 drops as STAT(once- single dose) will be applied on the skin in occlusive patch. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar)
2. Age group of 18 to 55 years, 12 male and 12 female subjects.
3. Compliance with the study procedures involved. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Subjects with any other skin disorders.
3. Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of mean scores of Erythema/dryness/wrinkles, Oedema and Mean Irritation Index |
Day 1,2,3 and 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| occurrence of any adverse effects. |
Day 1,2,3 and 8 |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| Date of Study Completion (India) |
21/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
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
|
24 adult healthy subjects will be selected for the study. The subjects selected for this study will be healthy females and males, aged between 18 and 55 years old. In which 12 will be females
and 12 will be male subjects. The entire study procedure, patch application, patch reading and grading is detailed in the protocol and followed as per the protocol. The Patch applied contain Finn’s chamber within which 2 drops of the test product will be filled in a separate chamber. The patch is applied on the back or shoulder area of the subjects and will be in contact with the skin for 24 hours. If the subject experiences any allergic reaction, the patch can be removed within 24 hours and reported to the investigator immediately. The mean scores of Erythema/dryness/wrinkles, Oedema and Mean Irritation Index will be calculated on day 1,2,3 and 8. |