| CTRI Number |
CTRI/2023/10/058603 [Registered on: 12/10/2023] Trial Registered Prospectively |
| Last Modified On: |
30/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeeutical] |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate irritation potential of test products by 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 Participants with Normal Skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B03444-MAY-A, Version: 01, Dated 18 Sep 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial 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 |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial 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
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,
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 |
|
|
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 |
| Maypop Beauty Pvt. Ltd.
Sector K-1090, Aashiyana Colony, Kanpur Road,
Lucknow, Uttar Pradesh - 226 012 |
|
|
Primary Sponsor
|
| Name |
Maypop Beauty Pvt. Ltd. |
| Address |
Sector K-1090, Aashiyana Colony, Kanpur Road, Lucknow, Uttar Pradesh - 226 012 |
| 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 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
bhagirathrpatel1818@gmail.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
|
|
|
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 |
Facial cleansing Elixir |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Intensive Nourishing Body Balm |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Intensive Repair Radiance Facial Oil |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Moisture Lock Age- Defying Stick Serum |
Neat, 0.04mg, single dose, topical application, 24 hr |
| 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 |
| Intervention |
Skin Resurfacing Exfoliant |
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. 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 (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) 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 6 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 self-reported 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 Investigator’s 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:
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 |
| 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)
|
25/10/2023 |
| Date of Study Completion (India) |
24/10/2023 |
| 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
|
N/A |
|
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. |