| CTRI Number |
CTRI/2023/03/050219 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Other |
|
Public Title of Study
|
Primary Irritation Patch Test (24-hour occlusion) with Sensitive Skin. |
|
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 Sensitive Skin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B02340-HON-N, Version: 01, Dated 14 Feb 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17 -20, Sigma I Corporates,
Opp. Mann Party Plot, Off S. G. Highway
Bodakdev, Ahmedabad – 380054 - India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17 -20, Sigma I Corporates,
Opp. Mann Party Plot, Off S. G. Highway
Bodakdev, Ahmedabad – 380054 - India
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17 -20, Sigma I Corporates,
Opp. Mann Party Plot, Off S. G. Highway
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, Block 17 -20, Sigma I Corporates, Opp. Mann Party Plot, Off S. G. Highway Bodakdev, Ahmedabad – 380054 - India |
|
|
Primary Sponsor
|
| Name |
Honasa Consumer Pvt. Ltd. |
| Address |
Mamaearth,
BLM Tower, 4th Floor,
Plot No. 63, Sector 44,
Gurgaon,
Haryana - 122003
|
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
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 Parth Joshi |
Cliantha Research |
Consumer Research Department,
Block 17 -20, Sigma I Corporates,
Opp. Mann Party Plot,
Off S. G. Highway
Bodakdev, Ahmedabad – 380054, India.
Ahmadabad
GUJARAT |
8000085049
pjoshi@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
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 of varied Skin types (Oily, Dry,
Normal and Combination) with normal Fitzpatrick
skin type III to V. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mamaearth Glow Serum Foundation O8 Natural Glow |
Neat, 0.04 ml, single dose,
topical application for 24 hrs |
| Intervention |
Mamaearth Glow Serum Foundation O9 Warm Glow |
Neat, 0.04 ml, single dose,
topical application for 24 hrs |
| Intervention |
Mamaearth Green Tea Under Eye Patches |
Neat, single dose, topical application for 24 hrs |
| Intervention |
Mamaearth Rice Sunscreen Gel |
Neat, 0.04 ml, single dose, topical application for 24 hrs |
| 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 |
|
|
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 negative urine pregnancy test performed on Day 00 prior to patch application.
5) Subjects scoring greater than 30 for Section 2-Sensitive versus Resistant skin in modified Dr. Baumann’s skin type questionnaire.
6) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
7) Subject is in good general health as determined by the Investigator on the basis of medical history.
8) Subjects willing to maintain the test patches in designated positions for 24 Hours.
9) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
10) Subject must be able to understand and provide written informed consent to participate in the study.
11) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given. |
|
| 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.
8) Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
9) Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
10) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
11) Subject with known allergy or sensitization to medical adhesives, bandages.
12) Participation in other patch study simultaneously.
13) 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 (steroidal 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)
|
07/03/2023 |
| Date of Study Completion (India) |
01/05/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cosmetics and Ayurvedic
Medicines 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. |