CTRI/2024/12/078199 [Registered on: 17/12/2024] 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 for 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-HON-C, Version: 01, Dated 29 Nov 24
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 Ltd
Mama Earth,
10th & 11th Floor,
Capital Cyberescape,
Sector 59, Gurugram,
Haryana- 122102
Primary Sponsor
Name
Honasa Consumer Ltd
Address
Mama Earth,
10th & 11th Floor,
Capital Cyberescape,
Sector 59, Gurugram,
Haryana- 122102
Type of Sponsor
Other [Health and Hygiene]
Details of Secondary Sponsor
Name
Address
NA
NA
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
ACEAS - Independent Ethics Committee
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 normal skin of varied Skin types (Oily, Dry, Normal and Combination).
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
Staze 9 To 9 Crème De La Matte Lipstick 08 Rum Royale
Neat, 0.04mg, single dose, topical application, 24 hr
Intervention
Staze 9 To 9 Pout On Lip Crayon 02 Very Bare
Neat, 0.04mg, single dose, topical application, 24 hr
Intervention
Staze 9 To 9 Pout On Lip Crayon 05 Cocoa Loco
Neat, 0.04mg, single dose, topical application, 24 hr
Intervention
The Derma Co. 1% Vitamin C Brightening Lip Balm
Neat, 0.04mg, single dose, topical application, 24 hr
Intervention
The Derma Co. Hypochlorous Anti-Acne Hydrating Spray
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
NA
NA
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)
03/01/2025
Date of Study Completion (India)
26/12/2024
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 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.