| CTRI Number |
CTRI/2025/04/085059 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Patch Test] |
| Study Design |
Other |
|
Public Title of Study
|
Primary Irritation Patch Test for assessing dermatological safety of test products on healthy Indian volunteers with normal skin. (Single 24-hour Application). |
|
Scientific Title of Study
|
Evaluation of dermatological safety of test products by Primary Irritation Patch Test on healthy subjects with normal skin. (Single 24-hour Application). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04942-ITC-B, Version: 01, Dated 07 Apr 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bpatel3@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Study Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054. Ahmedabad, Gujarat. |
| ITC Life Sciences & Technology Centre
Peenya Industrial area,
I Phase, Peenya
Bangalore- 560058
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences & Technology Centre |
| Address |
Peenya Industrial area,
I Phase, Peenya
Bangalore- 560058
Karnataka, India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054. Ahmedabad, Gujarat.
Ahmadabad
GUJARAT |
9825618138
bpatel3@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
19 to 65 years healthy Indian males and non-pregnant/non-lactating females with normal skin of varied Skin types (Oily, Dry, Normal and Combination). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
17-080F |
Product application as per BIS standard |
| Intervention |
17-100B |
Product application as per BIS standard |
| Intervention |
17-105A |
Product application as per BIS standard |
| Intervention |
17-106 |
Product application as per BIS standard |
| Intervention |
17-109A |
Product application as per BIS standard |
| Intervention |
17-109B |
Product application as per BIS standard |
| Intervention |
17-109C |
Product application as per BIS standard |
| Intervention |
18-037 A |
Product application as per BIS standard |
| Intervention |
18-037 B |
Product application as per BIS standard |
| Intervention |
18-037 C |
Product application as per BIS standard |
| Intervention |
18-037 D |
Product application as per BIS standard |
| Intervention |
18-043 A |
Product application as per BIS standard |
| Intervention |
187-29 |
Product application as per BIS standard |
| Intervention |
201-25 |
Product application as per BIS standard |
| Intervention |
B002 |
Product application as per BIS standard |
| Intervention |
HCL-039-065 |
Product application as per BIS standard |
| Intervention |
HCL-044-001 |
Product application as per BIS standard |
| Intervention |
HCL-41-047A |
Product application as per BIS standard |
| Comparator Agent |
Negative Control |
Product application as per BIS standard |
| Intervention |
OTC-016-064 |
Product application as per BIS standard |
| Comparator Agent |
Positive Controls |
Product application as per BIS standard |
| Intervention |
V362 |
Product application as per BIS standard |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Indian males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 19 to 65 years (both inclusive) at the time of consent.
2) Subjects with normal Fitzpatrick skin type III to V. (Human skin colour determination scale).
3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
4) Subjects who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
5) Subjects are in good general health as determined by the Investigator on the basis of medical history.
6) Subjects willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
7) Subjects willing and able to follow the study directions to participate in the study, return for all specified visits.
8) Subjects must be able to understand and provide written informed consent to participate in the study.
9) Subjects having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1) Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and 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) Subject with history of asthma or COPD (Chronic obstructive pulmonary disease), diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
3) Subject suffering from any active clinically significant skin diseases which may affect the study results.
4) Subject having history of any skin diseases including eczema, atopic dermatitis.
5) Participation in any patch test for irritation or sensitization within the last four weeks.
6) Subjects taking part in another study liable to interfere with the results of this study.
7) Subjects with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
8) Subjects with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the Subject ineligible or places the Subject at undue risk.
9) Subject with known allergy or sensitization to medical adhesives, bandages.
10) Use of any:
a. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
b. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
c. Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroids nose drops and/or eye drops are permitted).
d. Topical drugs used at application site. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety Assessment of Products |
24hrs post patch removal (Day 03) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety Assessment of Products |
30 mins post patch removal (Day 03)
and 7 days post patch application (Day 09)
|
|
|
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)
|
09/05/2025 |
| Date of Study Completion (India) |
03/05/2025 |
| 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
|
Single application, semi occlusive and closed occlusive patch study. Duration of study: 9 Days as per BIS Standard |