| CTRI Number |
CTRI/2022/03/040944 [Registered on: 09/03/2022] Trial Registered Prospectively |
| Last Modified On: |
18/04/2022 |
| 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 on Healthy Adult Human Subjects with Sensitive Skin |
|
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 Sensitive Skin. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B01122-CHA-A, Version: 01, Dated 01 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
|
|
|
Primary Sponsor
|
| Name |
Vedistry Pvt Ltd |
| Address |
Dr. Manisha Mishra Goswami
Medical Advisor
21, Evergreen Industrial Estate,
Shakti Mills Lane,
Off E. Moses Road, Mahalaxmi
Mumbai - 400011 |
| 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 |
Garden View Corporate House No. 7, Room No. 01, Consumer Research Department,
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 |
| ACEAS |
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) with normal Fitzpatrick skin type III to V. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
moha: Ultra-soothing Lotion |
Neat, 0.04 mg, 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 |
|
|
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) Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
4) Females of childbearing potential must have a negative urine pregnancy test performed on Day 00 prior to patch application.
5) Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire.
6) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
7) Subject is in good general health as determined by the Investigator on the basis of medical history.
8) Subjects willing to maintain the test patches in designated positions for 24 Hours.
9) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
10) Subject must be able to understand and provide written informed consent to participate in the study.
11) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given. |
|
| 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 product 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 |
| Not Applicable |
Not Applicable |
|
|
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)
|
14/03/2022 |
| Date of Study Completion (India) |
03/04/2022 |
| 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
|
|
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 (CIPT), human repeated
insult patch test (HRIPT) for irritation and sensitization potential.
Primary
Irritation Patch Test (PIPT) is used to determine the potential of the test
articles to cause cutaneous irritation in adult human subjects after single
24-hour occluded patch application.
Primary Irritation Patch Test (PIPT) 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. |