| CTRI Number |
CTRI/2024/04/066470 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check Skin Irritation potential of Hair Fibres. |
|
Scientific Title of Study
|
A Clinical Study to evaluate the skin irritation potential of Kerrato Hair Fibres on healthy human subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT171 Version 1.0 Dated 10 Feb 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
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 |
| Address |
1st Floor room 3, Skin testing lab ,CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| 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
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| Scinuvo Consumer Products LLP
Unit A-14, Balaji industrial park,Behind Hindalco, Tondre |
|
|
Primary Sponsor
|
| Name |
Scinuvo Consumer Products LLP |
| Address |
Unit A-14, Balaji industrial park,Behind Hindalco, Tondre |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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
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. This is a Irritation Patch Test Study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finn Chamber |
Each patch contains 0.04 ml or gm of 1.Kerrato Hair Fiber, 2. Negative control(0.9% NaCl, 3.Positive Control- 1% SLS Route of Administration: Topical Frequency: Once Duration: 24 hours |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Gender: Non-pregnant, non-lactating female aged between 18 to 65.
2)Subjects willing to give written informed consent
3)Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
4)Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
5)Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study. |
|
| 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 1 and Day 8 |
|
|
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)
|
10/05/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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. Kerrato Hair Fibres The product will be tested for skin irritation on 24 human volunteers.Assessment would be done on day 0, day 1, with followup visit on day 8 for erythema and Oedema scoring.
Study is done as per BIS standard 4011 |