| CTRI Number |
CTRI/2023/11/060303 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
To check the dermatological safety of the test products |
|
Scientific Title of Study
|
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects of varied skin types. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE/ITPT/2023-10, version 1.0, dated 13 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
navya.annam@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
navya.annam@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
navya.annam@msclinical.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences & Technology Centre, Peenya Industrial Area, I Phase, Peenya, Bangalore-560058, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences & Technology Centre |
| Address |
Peenya Industrial Area, I Phase, Peenya, Bangalore- 560058,
Karnataka, India |
| Type of Sponsor |
Other [FMCG (Fast moving Consumer Goods)] |
|
|
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
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 |
Human male and female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
13-102A |
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 |
| Intervention |
13-102B |
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 |
| Intervention |
15-109A |
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 |
| Intervention |
15-109B |
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 |
| Intervention |
15-109D |
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 |
| Intervention |
15-109E |
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 |
| Intervention |
B0362452D |
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 |
| Intervention |
HCL-033-091 |
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 |
| Intervention |
HCL-033-091a |
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 |
| Intervention |
HCL-034-030 |
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 |
| Intervention |
HCL-034-030a |
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 |
| Intervention |
HCL-32-046 |
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 |
| Intervention |
HCL-32-052(a) |
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 |
| Comparator Agent |
Negative control Isotonic Saline
- 0.9% |
40 microlitre of comparator
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 |
| Comparator Agent |
Positive control SLS - 1%
(PC-1) and 3% (PC-2) |
40 microlitre of comparator
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 |
| Intervention |
TSP 128-188 |
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 |
| Intervention |
TSP 141-113B |
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 |
| Intervention |
TSP 141-114B |
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 |
| Intervention |
TSP 141-114C |
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 |
| Intervention |
TSP 141-114D |
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 |
| Intervention |
TSP 141-155 |
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 |
| Intervention |
TSP 142-173 |
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 |
1. Subjects with Fitzpatrick skin type III to V.
2. 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.
3. Subject able to
read, understand and sign an appropriate informed consent form
indicating her willingness to participate.
4. Subjects willing to
give a voluntary written informed consent.
5. Subjects willing to
maintain the patch test in position for 24 hours.
6. Subject
having not participated in a similar investigation in the past two
weeks.
7. Subjects willing to come for regular follow up
visits.
8. Subjects ready to follow instructions during the study
period.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with infection, allergy on the tested area.
2. Subjects with skin allergy, antecedents or atopic subjects.
3. Athletes and subjects with history of excessive sweating.
4. Subjects with cutaneous disease which may influence the study
result.
5. Subjects on oral corticosteroid.
6. Subjects participating in any other cosmetic or therapeutic trial.
7. Subjects who are currently pregnant or lactating or planning to
become pregnant in the period of study.
8. Subjects with any history of underlying uncontrolled medical
illness including diabetes, liver disease or history of alcoholism, HIV
or any other serious medical illness.
9. More than one subject selected/ participating from one family/
household.
10. 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 |
To evaluate the dermatological safety of the
investigational products on healthy human
subjects |
Approximately 9 days for each subject |
|
|
Secondary Outcome
|
|
|
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 |
|
Date of First Enrollment (India)
|
06/12/2023 |
| Date of Study Completion (India) |
14/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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
|
It is a primary irritation patch test clinical study under dermatological
control. A patch test under occlusion is carried out using the occlusive
chambers prefixed to a micropore tape followed by an assessment.
This patch will then be applied on the test site i.e., between your scapulae
and waist on your upper back. The patch will be kept for 24 hours. After
which the patch will be removed and the first observation will be made at
30 minutes of patch removal (0 hr. reading). The further observations will
be at 24 hrs, and 1 week post patch removal. The dermatological
assessment will be done at each visit.
Study would be conducted over a period of 9 days and would include a
total of 4-5 visits. |