| CTRI Number |
CTRI/2024/10/075597 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Primary Prritation Patch Testing] |
| Study Design |
Other |
|
Public Title of Study
|
To check Dermatological Safety of Test Products through the 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 or Semi Occlusion or Open Patch on Adult Healthy Human Subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240058-TTK, 1.0, 26 Jul 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd
Office-A - 206, 2nd Floor,
Shaligram Lakeview Business Complex, Near Vaishnodevi Circle,
Khoraj.
Gandhinagar
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd
Office-A - 206, 2nd Floor,
Shaligram Lakeview Business Complex, Near Vaishnodevi Circle,
Khoraj.
GUJARAT
382421
India |
| Phone |
09909013286 |
| 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 |
NovoBliss Research Private Limited. Office-A - 206, 2nd Floor,
Shaligram Lakeview Business Complex, Near Vaishnodevi Circle,
Khoraj.
Gandhinagar
GUJARAT
382421
India |
| Phone |
09909013286 |
| 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] |
|
|
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 |
NovoBliss Research Pvt. Ltd.
Office A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382421,
Gujarat – India
Gandhinagar
GUJARAT |
09909013286
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 |
| Comparator Agent |
1% w/v
Sodium Lauryl Sulphate (SLS)
analytical grade |
Dose: 0.04mL Route of
administration: Topical Products
will be evaluated through the
complete occlusion or open
application for 24 hours. At 24
hours 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 |
Dose: 0.04mL Route of
administration: Topical Products
will be evaluated through the
complete occlusion or open
application for 24 hours. At 24
hours 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). |
| Intervention |
SKORE NOT OUT CLIMAX DELAY WIPES |
Dose: 0.04gm
Dosage Form: Wipes
Route of
administration: Topical
Mode of Usage:
products will be evaluated through the
complete occlusion patch for 24 hours. At 24
hours post-application, patches
will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours of (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed).
Frequency: onetime patch application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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).
3) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination
scale).
4) Females of childbearing potential must have a
self-reported negative pregnancy test.
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) Subject is in good general health as determined by the Investigator
on the basis of medical history.
7) Subjects is willing to maintain the test patches in 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) 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 instruction given.
11) For Sensitive Specific Skin Study Only.Subject scoring greater than 30 for Sensitive v/s Resistant skin in modified Dr Baumann’s skin type
questionnaire. Subject with sensitive skin as confirmed by Lactic Acid Stinging Test. |
|
| 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
Complete Occlusion on healthy adult human
subjects and adequate representation of varied
skin types (Oily, Dry, Normal and Combination) |
post patch removal at 30 min, 24 hours and 168 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Safety of the skin |
post patch removal at 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)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
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
|
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.
Visit 1 (Day 01): Screening Enrolment 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 contacted 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
|