CTRI/2022/03/040994 [Registered on: 10/03/2022] Trial Registered Prospectively
Last Modified On:
07/04/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Other (Specify) [Cosmoceutical]
Study Design
Other
Public Title of Study
Primary Irritation patch Testing (24 hrs).
Scientific Title of Study
Evaluation of Dermatological Safety of Test Products by Primary
Irritation Patch Test on Healthy Adult Human Subjects (Single 24-hour Application).
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
C3B01628-ITC-C, Version: 01, Dated 04 Mar 22
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,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad, India
Ahmadabad GUJARAT 380054 India
Phone
917966219500
Fax
917966219549
Email
pjoshi@ofacto.com
Details of Contact Person Scientific Query
Name
Dr Parth Joshi
Designation
Principal Investigator
Affiliation
Cliantha Research
Address
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad, India
GUJARAT 380054 India
Phone
917966219500
Fax
917966219549
Email
pjoshi@ofacto.com
Details of Contact Person Public Query
Name
Dr Simran Sethi
Designation
Director-Consumer Research
Affiliation
Cliantha Research
Address
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad, India
Ahmadabad GUJARAT 380054 India
Phone
917966219500
Fax
917966219549
Email
ssethi@ofacto.com
Source of Monetary or Material Support
Not Applicable
Primary Sponsor
Name
ITC Life Sciences Technology Centre
Address
Personal Care Division
ITC Life Sciences & Technology Centre,
Peenya Industrial area, I Phase, Peenya
Bangalore- 560058
Karnataka, India
Type of Sponsor
Other [Personal Care and Wellness Industry - India]
Details of Secondary Sponsor
Name
Address
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, Room No. 01, Garden View Corporate House No. 7, Opp. Auda Garden, Bodakdev, Ahmedabad 380054, India Ahmadabad GUJARAT
8000085049 917966219500 pjoshi@ofacto.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
OM IEC
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
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).
Intervention / Comparator Agent
Type
Name
Details
Intervention
Body Wash
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Body Wash
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
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
Comparator Agent
Positive Control
3 gm of SLS in 100 mL of distilled water (3 % w/v) , 0.04 mg, single dose, topical application, 24 hr
Intervention
Roll-On
Neat, 0.04 mg, single dose, topical application, 24 hr
Intervention
Skin Leave-on
Neat, 0.04 mg, single dose, topical application, 24 hr
Intervention
Skin Leave-on
Neat, 0.04 mg, single dose, topical application, 24 hr
Intervention
Skin Leave-on
Neat, 0.04 mg, single dose, topical application, 24 hr
Intervention
Skin Leave-on
Neat, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 0.04 mg, single dose, topical application, 24 hr
Intervention
Soap
8%w/v solution, 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) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
4) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
5) Subject is 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.
7) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
8) Subject must be able to understand and provide written informed consent to participate in the study.
9) Subject is willing to refrain from vigorous physical exercise during the study period.
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 article 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
NA
NA
Target Sample Size
Total Sample Size="26" Sample Size from India="26" Final Enrollment numbers achieved (Total)= "25" Final Enrollment numbers achieved (India)="25"
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.