| CTRI Number |
CTRI/2024/10/075779 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic study] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the safety of test material by using patch testing method. |
|
Scientific Title of Study
|
Evaluation of dermatological safety of
test materials by sequential patch
testing under complete occlusion in
adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAFE/DLPT/2024-01, Version: 2.0, Dated: 09 Sep 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| 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 |
918040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| 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 |
918040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Radha S |
| Designation |
Asst. Manager skin science |
| 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 |
918040917253 |
| Fax |
|
| Email |
radha@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Dermalogica, LLC.
1535 Beachey Place, Carson, CA 90746 |
|
|
Primary Sponsor
|
| Name |
Nelson Torres |
| Address |
Dermalogica, LLC.
1535 Beachey Place, Carson, CA 90746 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
327/15, 1st Main Road, Cambridge Layout
Ulsoor, Bangalore-560008,
Karnataka, India
Telephone: 91 80 40917253
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent 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 |
Extractant of entire sterile device in Saline |
250 microlitre of investigational
product
(as per the protocol) will be
applied back side of the subject.
Dose- 250ul Microlitre Frequency:
once during the study period for each time point.
Route of administration: Topical
Duration: For participants in part A duration of 12 days and participants in Part B duration of 7 days |
| Intervention |
Extractant of entire sterile device in Sesame oil |
250 microlitre of investigational
product
(as per the protocol) will be
applied back side of the subject.
Dose- 250ul Microlitre Frequency:
once during the study period for each time point.
Route of administration: Topical
Duration: For participants in part A duration of 12 days and participants in Part B duration of 7 days |
| Comparator Agent |
Negative control
(0.9% w/v) NaCl Sodium chloride injection I.P (Indian Pharmacopoeia). |
250 microlitre of investigational
product
(as per the protocol) will be
applied back side of the subject.
Dose- 250ul Microlitre Frequency:
once during the study period for each time point.
Route of administration: Topical
Duration: For participants in part A duration of 12 days and participants in Part B duration of 7 days |
| Comparator Agent |
Negative control
Sesame oil (British Pharmacopoeia grade) |
250 microlitre of investigational product (as per the protocol) will be applied back side of the subject. Dose- 250ul Microlitre Frequency: once during the study period for each time point. Route of administration: Topical Duration: For participants in part A duration of 12 days and participants in Part B duration of 7 days |
| Intervention |
Plastic disc from device (non-sterile) |
Plastic dis extracted from device |
| Comparator Agent |
Positive control
20% SDS w/v |
250 microlitre of investigational product (as per the protocol) will be applied back side of the subject. Dose- 250ul Microlitre Frequency: once during the study period for each time point. Route of administration: Topical Duration: For participants in part A duration of 12 days and participants in Part B duration of 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in age group 18 - 65 years (both the ages inclusive).
2. Healthy male & female subjects (at least one third of either sex)
3. Subjects in good health condition as per the health screening criteria with no
disease state or physical condition that the Investigator believes could interfere
with the interpretation of the data.
4. Subject able to read, understand and sign an appropriate informed consent
form indicating their willingness to participate.
5. Subjects willing to maintain the patch test in position for the required duration.
6. Subjects willing to come for regular follow-up visits.
7. Subjects with a broad upper back.
8. Subjects ready to follow instructions during the study period. |
|
| ExclusionCriteria |
| Details |
1. Subjects with known history of clotting or bleeding disorder such as
hemophilia(self- declared) .
2. Subjects with skin allergy, antecedents or atopic subjects.
3. Athletes and subjects with history of excessive sweating.
4. Subjects who is immunodeficient or immunosuppressed due to medical
condition or medication
5. Subjects taking anticoagulant therapies or low dose aspirin(self-declared).
6. Subjects with known sensitivity to the test material or showing any signs of
dermatitis.
7. Subjects prone to actinic keratoses and keloid scars.
8. Any systemic infection or disease that may affect the study as per PI ‘s
discretion, such as diabetes or cancer.
9. Subjects with cutaneous disease or skin infection, or damage at the site of
application which may influence the study result.
10. Subjects on oral corticosteroid or any other medication that may impact the
study results
11. Subjects who are currently pregnant or lactating or planning to become
pregnant in the period of study (self-declared).
12. Subjects with any history of underlying uncontrolled medical illness including
diabetes, liver disease or history of alcoholism, HIV or any other serious
medical illness.
13. More than one subject selected/participating from one family/household.
14. Subjects who are employees of MSCR or sponsor. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective
The objective of the study is to determine the irritation potential of the test
materials by a sequential patch test. |
15 min,30 min,1hour,2 hour,3 hour,4 hour,24 hour. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study consist of 2 parts, Part A and Part B in part A subjects will be exposed to test product using sequential patch testing method at time points , 15 mins,30 mins,1 hour, 2hour, 3 hour,4 hour followed by will be evaluated and will be scored using Human irritation score (Reference ISO 10993-23:2021(E)) at timepoints at +Timm,
+1hour,
+2hour,+24
hours,+48
hours and +
72 hours. If the participants with a pilot batch exposed in part A completes the study with no AE or AR, then the study will proceed with Part B there the subjects will be exposed to to 4 hours and 24 hours respectively and will be evaluated at same time points as Part A. |