| CTRI Number |
CTRI/2021/05/033830 [Registered on: 27/05/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Patch Test] |
| Study Design |
Other |
|
Public Title of Study
|
Primary patch irritation testing study |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Articles by Primary Irritation Patch Test on Healthy Adult Human Subjects (Single 24-hour Application) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00576, Batch 06 Version: 01, Dated 29 Oct 20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Phone 917966219500
Fax 917966219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Phone 917966219500
Fax 917966219549
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maheshvari Patel |
| Designation |
Associate Director Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Phone 917966219500
Fax 917966219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013236 |
| Fax |
07966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RiteStar Products Pvt Ltd |
| Address |
1106 or 7 Times Square Arcade
Opp Baghban Party Plot
Thaltej Ahmdebad
|
| Type of Sponsor |
Other [Personal Hygiene Wellness] |
|
|
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 Nayan Patel |
Cliantha Research |
Cliantha Research
Address: Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
9909013286
07966219549
nkpatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS - IEC |
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) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Facitize Face Shield Gel |
1.Neat, 0.04 mg, single dose, topical application |
| Comparator Agent |
10.Positive Control |
10. SLS 1 gm in 100 mL of distilled water (1 % w/v) , 0.04 mg, single dose, topical application |
| Comparator Agent |
11.Negative Control |
11.Neat / 0.9gm of Sodium Chloride in 100ml of distilled water (0.9% w/v) , 0.04 mg, single dose, topical application |
| Intervention |
2.Facitize Junior Face Shield Gel |
2.Neat, 0.04 mg, single dose, topical application |
| Intervention |
3.Foamtize Smart Hand Wash |
3. 8% w/v sample solution, 0.04 mg, single dose, topical application |
| Intervention |
4.Deotize Bloom Deo cum Sanitizer for Women |
4.Neat, 0.04 mg, single dose, topical application |
| Intervention |
5.Deotize Bliss Deo cum Sanitizer for Women |
5.Neat, 0.04 mg, single dose, topical application |
| Intervention |
6.Deotize Delight Deo cum Sanitizer for Men |
6.Neat, 0.04 mg, single dose, topical application |
| Intervention |
7.Deotize Desire Deo cum Sanitizer for Men |
7.Neat, 0.04 mg, single dose, topical application |
| Intervention |
8.Ambitize Air Sanitizer |
8.Neat, 0.04 mg, single dose, topical application |
| Intervention |
9.Utensitize Utensil Sanitizer |
9.Neat, 0.04 mg, single dose, topical application |
|
|
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 numbers 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 does 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. Subject 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, 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 with history of diabetes.
4. Subject with 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 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 (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, 24 hours and 168 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2021 |
| Date of Study Completion (India) |
04/06/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
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. The Test Products to be tested can involve Rinse-off products, Leave-on products for skin, Volatile substances, Talc products, Wipes etc. Along with this, different types of patches can be used for cosmeceuticals, pharmaceutical, herbal cream/lotions as well as herbal Transdermal/Topical patches can also be tested by using a similar outline To determine the potential of the test articles to cause cutaneous irritation in adult human subjects after single 24-hour occluded patch application.
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