| CTRI Number |
CTRI/2025/04/085060 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
Primary Irritation Patch Test (PIPT) on Healthy adult with Normal Skin (Single Application 24-hour Occlusion) |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects with Normal Skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04977-TLS-D, Version: 01, Dated: 08 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 |
Mr Satyendra Kumar |
| Designation |
Sr. Manager- Clinical Research |
| Affiliation |
Transformative Learning Solutions Pvt Ltd. |
| Address |
301B, 302-304, 3rd floor, Veritas Business Suite,
Sec-53, Gurgaon, Haryana 122002,
India
Gurgaon
HARYANA
122002
India |
| Phone |
9891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.in |
|
Details of Contact Person
Public 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 |
|
|
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-India
|
| Transformative Learning Solutions Pvt Ltd.
301B, 302-304, 3rd floor,
Veritas Business Suite,
Sec-53, Gurgaon, Haryana – 122002
|
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Pvt Ltd. |
| Address |
301B, 302-304, 3rd floor,
Veritas Business Suite,
Sec-53, Gurgaon, Haryana – 122002 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 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 |
| ACEAS - Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18 to 65 years healthy adult male & female with normal skin of varied Skin types (Oily, Dry, Normal and Combination). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative Control |
Neat, 0.9gm of Sodium Chloride in 100ml of distilled water (0.9% w/v) , 0.04 mg, single dose, topical application, 24 hr |
| Comparator Agent |
Positive Control |
1 gm of SLS in 100 mL of distilled water (1 % w/v) , 0.04 mg, single dose, topical application, 24 hr |
| Intervention |
TLS2324011NF02-008 (Serum) |
Neat, 0.04mg, single dose, topical application, 24 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent.
2) Participants 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) Participants 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) Participants are in good general health as determined by the Investigator on the basis of medical history.
6) Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
7) Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
8) Participants must be able to understand and provide written informed consent to participate in the study.
9) Participants having valid proof of identity and age.
|
|
| ExclusionCriteria |
| Details |
1) Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (example tattoos, scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) that is back that can interfere with the reading.
2) Participant 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 six months.
3) Participant suffering from any active clinically significant skin diseases which may affect the study results.
4) Participant 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) Participants taking part in another study liable to interfere with the results of this study.
7) Participants with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
8) Participants with a medical condition or are taking or have taken a medication which, in the Investigators judgment, makes the Participant ineligible or places the Participant at undue risk.
9) Participant 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 days prior to application.
b. Antihistamine medication or immunosuppressive drugs within seven days prior to first patch application.
c. Systemic or topical corticosteroids at patch site within four weeks of test product application (steroidal 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 |
| To evaluate the dermatological safety of the test products by 24 Hours Patch Test Under Complete Occlusion on healthy human participants with normal skin. |
30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
08/05/2025 |
| Date of Study Completion (India) |
30/04/2025 |
| 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
|
Cosmetics products commonly referred to as personal care products are
used by most people on a day-to-day basis. These products and materials can be
potential sources of cutaneous irritation which makes it a necessity to ensure
their safety for usage.
Several types of test methods are used widely for the evaluation of
safety of cosmetics in human, which include single patch test, in-use test,
7/14/24 days cumulative irritation patch testing (CIPT), human repeated insult
patch test (HRIPT) for irritation and sensitization potential.
Primary Irritation Patch Test (PIPT) is performed to evaluate the
primary skin irritation that can range from none, mild, moderate to severe
irritation. This results from reversible inflammatory changes in the skin
following the application of a test substance depending on the irritation
potential of the product. Based on the severity of irritation caused due to the
interaction of ingredients or composition of the test substance with the skin
can cause perceivable sensations or symptoms. On the basis of this, the
possible hazards likely to arise from exposure of the skin to the test
substance can be assessed. To know the safety or possible irritant potential of
these products, it should be tested in small group of humans before release of
the product in market. This allows to measure and evaluate the probable
inflammatory response to an irritant which occurs only at the site of exposure.
The response tends to be universal (produces a reaction in most individuals) and
depends on the strength and duration of exposure. |