| CTRI Number |
CTRI/2025/06/089311 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[Primary Irritation Patch Testing] |
| Study Design |
Other |
|
Public Title of Study
|
To check Dermatological Safety of Test Product by 24 Hours Primary Irritation Patch Testing 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 |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250023-NL Version 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 - Medical Director |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India
Ahmadabad
GUJARAT
382481
India
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 Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India
Ahmadabad
GUJARAT
382481
India
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 Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT 382481 India
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Novamed Laboratories Pvt. Ltd. Plot No. 3, Sector 16,
HSIIDC Industrial Estate Bahadurgarh,
Haryana – 124507, India |
|
|
Primary Sponsor
|
| Name |
Novamed Laboratories Pvt. Ltd. |
| Address |
Plot No. 3, Sector 16,
HSIIDC Industrial Estate Bahadurgarh,
Haryana – 124507, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
Clinical Trial Department NovoBliss Research Pvt. Ltd. Office 313,
Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
382481. Gandhinagar GUJARAT
382421 India Ahmadabad
GUJARAT
Ahmadabad
GUJARAT
Ahmadabad
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 |
| Intervention |
1 cm2 Capsaicin 0.025% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Diclofenac Diethylamine 100 mg Transdermal Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of
usage: Products will be evaluated through the complete
occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Diclofenac Diethylamine 200 mg Transdermal Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Diclofenac Sodium 140 mg Gel Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Ketoprofen 20 mg Transdermal Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Ketoprofen 30 mg Transdermal Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Lidocaine & Menthol Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Lidocaine 350 mg Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Lidocaine 4% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 1.25% Camphor 3% Capsaicin 0.025% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 1.25% Capsaicin 0.025% Topical Patch
|
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 10% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 5% Hydrogel Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 5% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 6.0% Camphor 3.1% Methyl
Salicylate 10%
|
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 6.5% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 7% Camphor 7% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Intervention |
1 cm2 Menthol 7.5% Topical Patch |
Dose: 1×1 cm Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion 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). Frequency: single application Duration: 09 days |
| Comparator Agent |
Positive Control- 1% 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. 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). Frequency: single
application Duration: 09 Days |
| Comparator Agent |
sodium chloride
(Isotonic Saline
Solution)
Injection IP 0.9
% 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. 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). 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. 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. |
|
|
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
product by 24 Hours Patch Test Under
Complete Occlusion on healthy adult human
subjects and adequate representation of
varied
skin types (Oily, Dry, Normal, Sensitive and
Combination) |
To evaluate the dermatological safety of the
test product by 24 Hours Patch Test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the dermatological safety of the test product |
Post patch removal of 30 mins, 24 hours & 168
hours |
|
|
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)
|
11/07/2025 |
| Date of Study Completion (India) |
29/07/2025 |
| 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 if subject under inclusion | semi occlusion | open patch 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 are optional visit pre-screening visit: Lactic Acid Stinging test & Modified Dr baumenn’s skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01) Visit 02: Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: 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) |