| CTRI Number |
CTRI/2025/10/095542 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Primary Irritation Patch Testing] |
| Study Design |
Other |
|
Public Title of Study
|
Primary Irritation Patch Testing of test product for skin safety |
|
Scientific Title of Study
|
Dermatological Safety Assessment of Test Products Using Primary Irritation Patch Test (PIPT) in Healthy Adult Human Subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250039-MM, Version 1.0, 12 Jun 25 |
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 |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
917948983895 |
| 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 |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
917948983895 |
| 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 Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Mor Medics Science and Technologies |
|
|
Primary Sponsor
|
| Name |
Mor Medics Science and Technologies |
| Address |
E-657, Focal Point,
Phase-VIII, Ludhiana,
Punjab - 141010
|
| Type of Sponsor |
Other [personal care and hygiene manufacturer] |
|
|
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 Nayan Patel |
NovoBliss Research Private Limited |
313, Silver Radiance-4,Gota,Ahmedabad, Gujarat, India-382481. Ahmadabad GUJARAT
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
07948983895
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 |
MEE MEE 99% Pure Water Wipes |
Route of administration: Topical
mode of usage: Products will be evaluated through the complete occlusion application for 24 hours. At 24hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins, 24hours (Day1) post patch removal and 168hours(Day 7) post-patch removal (if needed).Frequency: single application Duration:09 Days |
| Intervention |
MOM Wishes 99% Pure Water Baby Wipes |
Route of administration: Topical mode of usage: Products will be evaluated through the complete occlusion application for 24 hours. At 24hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins, 24hours (Day1) post patch removal and 168hours(Day 7) post-patch removal (if needed).Frequency: single application Duration:09 Days |
| Comparator Agent |
Positive Control-1%w/v SLS or 3%w/v SLS |
Dose: 0.04mL Route of administration: Topical mode of usage:Products will be evaluated through the complete occlusion or semi occlusion application for 24 hours. At24hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins, 24hours(Day 1) post patch removal and 168 hours(Day 7) post-patch removal (if needed).Frequency: single application Duration: 09 Days |
| Comparator Agent |
sodium chloride(Isotonic Saline Solution)Injection IP0.9% w/v |
Dose: 0.04mL Route of administration: Topical mode of usage:Products will be evaluated through the complete occlusion or semi occlusion application for 24 hours. At24hours post-application, patches will be removed and skin will be evaluatedfor irritation reactions at 30 mins, 24hours(Day 1) post patch removal and 168 hours(Day 7) post-patch removal (if needed).Frequency: single application Duration: 09 Days |
|
|
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).
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 Section 2 – 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. backthat 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 thepast year, or treatment of any type of cancer within the last 6 months.
5) Subject suffering from any active clinically significant skin diseases which maycontraindicate.
6) Subject having history of any skin diseases including eczema, atopic dermatitis or activecancer.
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 toapplication.
ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior tofirstpatch application.
iii. Systemic or topical corticosteroids at patch site within four (4) weeks of testproductapplication (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, AIDSand/orsystemic lupus erythematous.
12) Individual who has a medical condition or is taking or has taken a medication which,in theInvestigator’s judgment, makes the subject ineligible or places the subject atundue 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
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the dermatological safety of the test products by 24 Hours Patch Test |
To evaluate the dermatological safety of the test products by 24 Hours Patch Test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the skin |
At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required. |
|
|
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)
|
15/10/2025 |
| Date of Study Completion (India) |
15/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
|
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 single-centre, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 24 hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total three visits in this study and one are optional visit. Visit 01 (Day01):Screening, Lactic Acid Stinging Test& Modified Dr Baumann’s skin type questionnaire, Enrollment and Patch Application, Visit 02 (Day 02):Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03(Day 03): 24 (± 2 hour) irritation scoring (Day 03)Visit04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery(optional deemed necessary)Irritation scoring at 168 ± 2 hours post-patch removal(Day 09). |