| CTRI Number |
CTRI/2024/02/062575 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity test] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the test products safety |
|
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/2024-01, version 1.0, dated 11 January 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navya Annam |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research |
| Address |
Ground floor, Sensitivity Dept, no. 1, 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 |
Satyendra Kumar |
| Designation |
Sr. Manager - Clinical Research |
| Affiliation |
Transformative Learning Solution Pvt. Ltd. |
| Address |
3rd Floor, Veritas Tower, Sector 53, Gurugram
Gurgaon
HARYANA
122002
India |
| Phone |
9891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.in |
|
Details of Contact Person
Public Query
|
| Name |
Radha S |
| Designation |
Study Manager |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Ground floor, Sensitivity Dept, no. 1, 327/15, 1st Main Road,
Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
radha@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Transformative Learning Solutions Pvt Ltd, 3rd Floor, Veritas Business Suit, Sector 53, Gurgaon,
Haryana 122002
|
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Pvt Ltd |
| Address |
3rd Floor, Veritas Business Suit, Sector 53, Gurgaon, Haryana
122002 |
| 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 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 |
Healthy male and female subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Line-Tune Peptide Full-Filling
Day Cream |
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 (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 |
|
|
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 with skin types as defined in the population details under appendix 1.
3. 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.
4. Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
5. Subjects willing to give a voluntary written informed consent.
6. Subjects willing to maintain the patch test in position for 24 hours.
7. Subject having not participated in a similar investigation in the past two weeks.
8. Subjects willing to come for regular follow up visits.
9. 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 or participating from one family or household.
10. Subjects working with MSCR |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the potential irritation of the test
formulation on topical application in skin type
human volunteers under controlled patch study
conditions in a PIPT test. |
0 h, 24 h, 7 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2024 |
| Date of Study Completion (India) |
29/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/02/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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. |