| CTRI Number |
CTRI/2025/06/088891 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| 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 Normal Skin (Single Application 24 hours 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-HON-N, Version: 01, Dated 04 Jun 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-India
|
| Honasa Consumer Limited.
10th & 11th Floor,
Capital Cyberescape,
Sector 59,Gurugram, Haryana-122102
|
|
|
Primary Sponsor
|
| Name |
Honasa Consumer Limited. |
| Address |
10th & 11th Floor,
Capital Cyberescape,
Sector 59,Gurugram, Haryana-122102
|
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
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 Parth Joshi |
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, Gujarat
Ahmadabad
GUJARAT |
8000085049
pjoshi@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 |
| Intervention |
Aqualogica Bright+ make-up set Sunscreen mist |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Aqualogica Radiance+ Dewy Sunscreen |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Dr. Sheth’s Kesar & Kojic acid Moisturizing Cream |
Neat, 0.04mg, single dose, topical application, 24 hr |
| 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 |
The Derma Co. 1% Hyaluronic Sunscreen Aqua Gel |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
The Derma Co. 2% Kojic acid face 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) 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:
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 (steroids nose drops and/or eye drops are permitted).
IV. 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 |
30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
08/07/2025 |
| Date of Study Completion (India) |
02/07/2025 |
| 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
|
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, human repeated insult patch test (HRIPT) for
irritation and sensitization potential.
Primary
Irritation Patch Test 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. |