| CTRI Number |
CTRI/2024/05/068064 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin sensitivity test] |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Dermatological Safety. A 24-Hour Patch Test Study on Healthy Individuals Under Complete Occlusion. |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE/MSPT/2024-09, Version: 1.0, Dated: 16 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sukrutha S D |
| Designation |
Principal Investigators |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
327/15, 1st Main Road
Cambridge Layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
7760530477 |
| Fax |
|
| Email |
dr.sukrutha@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukrutha S D |
| Designation |
Principal Investigators |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
327/15, 1st Main Road
Cambridge Layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
7760530477 |
| Fax |
|
| Email |
dr.sukrutha@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukrutha S D |
| Designation |
Principal Investigators |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
327/15, 1st Main Road
Cambridge Layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
7760530477 |
| Fax |
|
| Email |
dr.sukrutha@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Jenburkt Pharmaceuticals Ltd.
93,J.P Road, Andheri (west) ,Mumbai-400058
|
|
|
Primary Sponsor
|
| Name |
Jenburkt Pharmaceuticals Ltd. |
| Address |
93,J.P Road, Andheri (west) ,Mumbai-400058 |
| 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 Sukrutha SD |
MS Clinical Research |
MS Clinical Research Pvt. Ltd
327-15, 1st Main Road
Cambridge Layout, Ulsoor
Bangalore 560008,
Karnataka, India
Bangalore
KARNATAKA |
8040917253
dr.sukrutha@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative Control(0.9% Isotonic
Saline) |
40 microlitre of Negative control
(0.9% Isotonic Saline) will be
applied on the back side of the
subject along with the test
products. Dose- 40 Microlitre
Frequency- once during the
study period Route of
administration- Topical
Duration: 9 days for each
subject |
| Comparator Agent |
Positive Control (1% SLS) |
40 microlitre of Positive control
(1% SLS) will be applied on the
back side of the subject along
with the test products. Dose- 40
Microlitre Frequency- once
during the study period Route of
administration- Topical
Duration: 9 days for each
subject |
| Intervention |
RDZSB2401 |
40 microlitre of investigational
product with or without dilution
(as per the protocol) will be
applied back side of the subject.
Dose- 40 Microlitre Frequency:
once during the study period
Route of administration: Topical
Duration: 9 days for each
subject |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects in age group 18 - 65 years (both the ages inclusive).
Healthy male & female subjects.
Subjects in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
Subject able to read, understand and sign an appropriate informed consent form indicating their willingness to participate.
Subjects willing to maintain the patch test in position for 24 hours.
Subjects willing to come for regular follow-up visits.
Subjects ready to follow instructions during the study period.
|
|
| ExclusionCriteria |
| Details |
Subjects with infection or any skin indications at the test area i.e. back of the subjects.
Subjects with known history of skin allergy, antecedents or atopic subjects.
Athletes and subjects with history of excessive sweating.
Subjects with cutaneous disease which may influence the study result.
Subjects on oral corticosteroid.
Subjects participating in any other cosmetic or therapeutic trial.
Subjects who are pregnant or nursing (self-declared).
Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
Subjects working with MSCR.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of the study is to determine the potential irritation of the test formulation in different skin types in a PIPT test. |
Baseline,20-30 minutes,24 hours, Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/06/2024 |
| Date of Study Completion (India) |
13/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 study consists of single application of sample on the upper back of human participants, under occlusive patch for the duration of 24 hour of exposure. After removal of patches post 24 hr. The assessment of skin reaction needs to be evaluated subjectively using the Draize Scale 24hour removal of patches. Follow up reactions will be done one week thereafter to confirm recovery. |