CTRI/2024/10/075294 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On:
16/12/2024
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 (Single Application 24-hour Occlusion Patch Test) for Normal Skin with varied skin types (oily, dry, normal and combination).
Scientific Title of Study
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Normal Skin.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
C3B03444-ZYD-A, Version: 01, Dated 02 Oct 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
Zydus Wellness Products Limited,
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment, Opp Viola Apartment,
Ambli Bopal Road, Ahmedabad 380015
Primary Sponsor
Name
Zydus Wellness Products Limited
Address
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment, Opp Viola Apartment,
Ambli Bopal Road, Ahmedabad 380015
Type of Sponsor
Other [Health and Hygiene]
Details of Secondary Sponsor
Name
Address
NIL
NIL
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. 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).
Intervention / Comparator Agent
Type
Name
Details
Intervention
Everyuth Naturals Anti-Pollution Pink Clay & Charcoal Face Pack
Neat, 0.04mg, single dose, topical application, 24 hr
Intervention
Everyuth Naturals Anti-Pollution Pink Clay & Charcoal Face Wash
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
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. (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) 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.
5) Participants are in good general health as determined by the Investigator on the basis of medical history.
6) Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
7) Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
8) Participants must be able to understand and provide written informed consent to participate in the study.
9) Participants having valid proof of identity and age.
ExclusionCriteria
Details
1) Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (example tattoos, scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) that is 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 six 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 selfreported 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 Investigators 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:
a. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five days prior to application.
b. Antihistamine medication or immunosuppressive drugs within seven days prior to first patch application.
c. Systemic or topical corticosteroids at patch site within four weeks of test product application (steroidal nose drops and or eye drops are permitted)
d. 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"
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.
Score the reaction, namely, erythema, dryness, wrinkles on a 0–4-point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale per below table:
Draize Scale for Scoring the Application Sites
Score for Erythema/ Dryness/ wrinkles
Reaction
Score for Oedema
Reaction
0
No reaction
0
No reaction
1
Very slight erythema/dryness with shiny appearance
1
Very slight oedema
2
Slight erythema/ dryness/ wrinkles
2
Slight oedema
3
Moderate erythema/ dryness/ wrinkle
3
Moderate oedema
4
Severe erythema/ wrinkle/ scale
4
Severe oedema
Four parameters namely erythema/dryness/wrinkles and oedema will be scored separately on irritation scoring sheet, however, highest score of erythema, dryness and wrinkles will be taken for calculation of Mean Irritation Score (MIS).
Mean Score for Irritation = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each sample / Total no. of Participants