| CTRI Number |
CTRI/2025/11/097816 [Registered on: 21/11/2025] 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 on Sensitive Skin |
|
Scientific Title of Study
|
A non-randomized, evaluator-blinded, single center study to evaluate the dermatological safety of Test Products by Primary Irritation Patch Test on Adult Healthy Human Participants with Sensitive Skin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B06081-HON-A, Version: 01, Dated 28 Oct 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 |
Senior 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 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, 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 |
18 to 65 years healthy adult male & female with sensitive skin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mamaearth Baby Moisturizing daily lotion |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Mamaearth Lemon Anti-Dandruff Conditioner |
8% w/v Sample Solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Mamaearth Lemon Anti-Dandruff Shampoo |
8% w/v Sample Solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Mamaearth Neem Clear Skin Face Wash |
8% w/v Sample Solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Mamaearth Onion Hair fall Control Shampoo |
8% w/v Sample Solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Mamaearth Rosemary Anti-Hair fall Conditioner |
8% w/v Sample Solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Mamaearth Tea Tree Pimple Control Face Wash |
8% w/v Sample Solution, 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 ml, 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 ml, 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.
3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
4) Participants scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire.
5) 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.
6) Participants are in good general health as determined by the Investigator on the basis of medical history.
7) Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
8) Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
9) Participants must be able to understand and provide written informed consent to participate in the study.
10) Participants should be literate and able to read and write (English or Hindi or local language).
11) Participants having valid proof of identity and age.
|
|
| ExclusionCriteria |
| Details |
1) Participants 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) 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 6 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 Investigator’s 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:
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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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. |