| CTRI Number |
CTRI/2023/06/053467 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[Primary Irritation Patch Testing]] |
| Study Design |
Other |
|
Public Title of Study
|
To check the safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects. |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete
Occlusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NBSP23-PIPT-0009-TTK Version 01 28Sep22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| TTK Healthcare Ltd Protective Devices Division Research and Development No.3,
Thiruneermalai Road, Chrompet, Chennai – 600 044, Tamil Nadu - India |
|
|
Primary Sponsor
|
| Name |
TTK Healthcare Ltd Protective Devices Division |
| Address |
Research and Development No.3, Thiruneermalai Road, Chrompet,
Chennai – 600 044, Tamil Nadu - India |
| Type of Sponsor |
Other [FMCG Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Pvt. Limited |
Office-A - 206, 2nd
Floor, Shaligram
Lakeview, Nr.
Vaishnodevi Circle,
Khoraj, Gandhinagar –
382421, Gujarat - India
Department - Clinical
Trials Gandhinagar
Gandhinagar
GUJARAT |
9909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adequate representation of varied skin types.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cosmetic Gel |
Products will be evaluated
through the complete occlusion
or open application for 24 hours.
At 24hours post-application,
patches will be removed and
Skin will be evaluated for
irritation reactions at 30 mins,24
hours (Day 1) post patch
removal and 168 hours (Day 7)
post-patch removal (if needed) |
| Comparator Agent |
Negative Control - Sodium
chloride (Isotonic Saline
Solution) Injection IP 0.9 % w/v |
Products will be evaluated
through the complete occlusion
or semi occlusion application for
24 hours. At 24hours
post-application, patches will be
removed and skin will be
evaluated for irritation reactions
at 30 mins, 24 hours (Day 1)
post patch removal and 168
hours (Day 7) post-patch
removal (if needed). |
| Comparator Agent |
Positive Control - 1% w/v
Sodium Lauryl Sulphate (SLS)
analytical grade |
Products will be evaluated
through the complete occlusion
or semi occlusion application for
24 hours. At 24hours
post-application, patches will be
removed and skin will be
evaluated for irritation reactions
at 30 mins, 24 hours (Day 1)
post patch removal and 168
hours (Day 7) post-patch
removal (if needed). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18-65 years (both inclusive) at the time of consent.
2. Sex: Males and non-pregnant/non-lactating females
(preferably equal number of males and females).
colour determinationbr/> scale).
4. Females of childbearing potential must have a negative urine pregnancy test performed
on Day 01 prior to patch application.
5. Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the
results.
6. The subject is in good general
health as
determined by the Investigator on the basis of medical history.
7. Subjects are willing to maintain the test patchesin designated positions for 24 Hours.
8. Subject is willing
and able to follow the study directions, to participate in the study, returning for all specified visits.
9. The subject must be able to understand and provide written informed consent to participate in the study.
10. Subject is willing to refrain
from vigorous physical exercise during the study period and follow all the instructions given. |
|
| ExclusionCriteria |
| Details |
1. Subject having skin irritation, blemishes, excessive hair, moles,
pigmentation, pimples, marks (e.g. tattoos (within the previous 3
months), scars, sunburn), open wounds, cuts, abrasions, irritation
symptoms or any dermatological condition on the test site(s) i.e.
back that can interfere with the reading.
2. Medication which may affect skin response and/or past medical
history.
3. Subject having history of diabetes
4. Subject have history of mastectomy for cancer involving removal
of lymph nodes within the past year, or treatment of any type of
cancer within the last 6 months.
5. Subject suffering from any active clinically significant skin
diseases which may contraindicate.
6. Subject having history of any skin diseases including eczema,
atopic dermatitis or active cancer.
7. Participation in any patch test for irritation or sensitization within
the last four weeks.
8. Subject having history of asthma or COPD (Chronic obstructive
pulmonary disease).
9. Use of any:
i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within
five (5) days prior to application.
ii. Antihistamine medication or immunosuppressive drugs within
seven (7) days prior to first patch application.
iii. Systemic or topical corticosteroids at patch site within four (4)
weeks of test product application (steroidal nose drops and/or eye
drops are permitted)
10. Topical drugs used at application site.
11. Subject with Self-reported Immunological disorders such as HIV
positive, AIDS and/or systemic lupus erythematous.
12. Individual who has a medical condition or is taking or has taken a
medication which, in the Investigator’s judgment, makes the subject
ineligible or places the subject at undue risk.
13. Subject with known allergy or sensitization to medical adhesives,
bandages.
14. Participation in other patch study simultaneously. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the dermatological safety of the test
products by 24 Hours Patch Test Under
30 mins, 24 Hour & 168 hour if needed.
Complete Occlusion on healthy adult human
subjects & adequate representation of varied
skin types (Oily, Dry, Normal and Combination) |
30 mins, 24 Hour & 168 hour (if needed).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Skin |
30 mins, 24 Hour & 168 hour (if needed).
|
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2023 |
| Date of Study Completion (India) |
28/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Single-center, Evaluator blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative control will be kept in contact with subjects’ skin under occlusion| semi-occlusion patch for at least 24 hr. 26 subjects of varied skin types (Oily, Dry, Normal, and Combination preferably equal ratio will be enrolled into the study to get 24 completed subjects at the end of study There are three visits in this study and one optional visit. Pre-Screening: Lactic Acid Stinging Test and Modified Dr Baumann’s kin type questionnaries Visit 1 (Day 01): Screening Enrollment and patch Application Visit 2 (Day 02): Patch Removal after 24 hours of patch application & 30+5 min Irritation scoring upon patch removal Visit 3(Day 03): 24 ±2 hours Irritation scoring after path removal Visit 4 (Day 09): Subject will be contact telephonically on Day 8 for any sign of irritation at the patch application site. follow-up visit for reactions if any to confirm recovery(optional, if deemed necessary) [irritation scoring at 168+2 hours post-patch removal |