| CTRI Number |
CTRI/2023/11/059663 [Registered on: 08/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity Test] |
| Study Design |
Other |
|
Public Title of Study
|
safety of the test product to be checked |
|
Scientific Title of Study
|
Evaluation of skin sensitization potential of investigational products by Human Repeat Insult Patch Test (HRIPT) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE-MSHR-2023-06, ver 1.0, dated 17 oct 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore- 560008, Karnataka, India.
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
navya.annam@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore- 560008, Karnataka, India.
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
navya.annam@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore- 560008, Karnataka, India.
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
navya.annam@msclinical.com |
|
|
Source of Monetary or Material Support
|
| HNL Business Services India Private Limited
Ground and first floor, Tower C, Prestige Shantiniketan, Krishnarajapuram Hobli, Bangalore South Taluk, Bangalore urban,
Karnataka-560048, India |
|
|
Primary Sponsor
|
| Name |
HNL Business Services India Private Limited |
| Address |
HNL Business Services India Private Limited
Ground and first floor, Tower C, Prestige Shantiniketan, Krishnarajapuram Hobli, Bangalore South Taluk, Bangalore urban,
Karnataka-560048, India |
| Type of Sponsor |
Other [Research and Development] |
|
|
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 Navya Annam |
MS Clinical Research Pvt. Ltd |
Ground Floor, Sensitivity room, Room No. 1, 327/15, 1st Main Road Cambridge Layout, Ulsoor Bangalore-560008, Karnataka, India.
Bangalore
KARNATAKA |
08041125934
08040917253
navya.annam@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Facial Toner-PAL/VLTN-E/23-001 |
40 microlitre of investigational product without dilution will be applied on the back of the subject.
Dose- 40 microlitre.
Route of administration- Topical
Duration- 45 days for each subject |
| Comparator Agent |
Negative control-0.9% isotonic saline |
40 microlitre of investigational product without dilution will be applied on the back of the subject.
Dose- 40 microlitre.
Route of administration- Topical
Duration- 45 days for each subject |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects 18 to 65 years (both inclusive) of age.
2. Subjects with skin photo type III to V
3. Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.
4. The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.
5. Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study.
6. Subjects must have clear back. They should not have any infection or allergy on the tested area. They should have healthy skin (Healthy skin is smooth, with no breaks in the surface. It is devoid of any rashes, scars, bumps etc.) on test area
7. Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures
8. Subjects having valid proof of identity and age.
9. Willingness to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study |
|
| ExclusionCriteria |
| Details |
1. Pregnant women/ Nursing mothers
2. Presence of scars, excessive terminal hair or tattoo on the studied area.
3. Henna tattoo seen on the test site of the body.
4. Dermatological infection/pathology on the level of studied area
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
6. Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures, as evaluated by the study PI and co-PI.
7. Chronic illness which may influence the outcome of the study.
8. Subject 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.
10. Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision
11. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the dermatological safety of the investigational products on healthy human subjects |
Approximately 45 days for each subject |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2023 |
| Date of Study Completion (India) |
05/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 evaluation
of substances for potential skin irritation and sensitization requires thorough
assessment before human testing. This assessment involves confirming the safety
of all ingredients based on existing research or alternative methods. A
standardized, repeatable patch testing procedure is essential to demonstrate
the safe application of a material on human skin without significant risk of
adverse reactions. The Human Repeat Insult Patch Test (HRIPT) is the standard
approach for diagnosing contact allergies due to type IV hypersensitivity,
involving repeated occlusive patch application for three weeks, followed by a
challenge. The study design follows IS 4011:2018 guidelines and consists of
four phases: induction, rest, challenge, and re-challenge. The objectives
include determining sensitization potential and cumulative irritation potential
through nine occlusive applications. The study involves 100 healthy subjects with
various skin types, and screening ensures compliance with inclusion/exclusion
criteria and informed consent. |