| CTRI Number |
CTRI/2020/06/025633 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Sensitivity Test] |
| Study Design |
Other |
|
Public Title of Study
|
Human Repeat Insult Patch Testing. |
|
Scientific Title of Study
|
Evaluation of the Cumulative Irritation and Potential for Sensitization of Test Products in Healthy Adult Human Subjects by Repeat Insult Patch Testing. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KLS20-AIL-001 Version 02 Dated 16 May 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
Cliantha Research
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
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
Cliantha Research
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
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
Cliantha Research
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013236 |
| Fax |
07966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Azafran Innovacion Limited |
| Address |
Dishman Corporate House
Jayantilal Park BRTS Bus Stop
Iscon-Bopal Road Ambli
Ahmedabad, Gujarat 380009 |
| Type of Sponsor |
Other [Cosmetics Industries] |
|
|
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 |
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
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
| Riddhi Medical Nursing Home |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18 to 65 years adult male & female subjects having apparently healthy skin on studied area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 Baby massage oil
2 Baby moisturizing soap that is jasmine fragrance
3 Baby gentle body wash and shampoo
4 Baby nourishing cream with chamomile extract
5 Baby diaper rash cream that is jasmine fragrance
6 Nutri active advance skin firming cream
7 Dfend Spf50plus Cream
8 Skin brightening cream
9 Daily 3 in 1 Moisturizer
10 Soya rich triple action shampoo |
1 0.04 ml of product will be applied and occluded.
2 0.04 ml of product will be applied and occluded.
3 0.04 ml of product will be applied and occluded.
4 0.04 ml of product will be applied and occluded.
5 0.04 ml of product will be applied and occluded.
6 0.04 ml of product will be applied and occluded.
7 0.04 ml of product will be applied and occluded.
8 0.04 ml of product will be applied and occluded.
9 0.04 ml of product will be applied and occluded.
10 0.04 ml of product will be applied and occluded. |
| Comparator Agent |
1 Positive Control |
1 Sodium Lauryl Sulphate (SLS) analytical grade 0.1 % w/v will be applied. |
|
|
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) Subjects who do not have any previous history of adverse skin conditions and are not under any medication 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 and able to follow the study directions, to participate in the study, returning for all specified visits.
7) Subjects must be able to understand and provide written informed consent to participate in the study.
8) Subjects willing to shower using the same soap/cleansers between Screening and End of the Study.
9) Subjects willing to refrain from vigorous physical exercise during the study period. |
|
| ExclusionCriteria |
| Details |
1) Subject is pregnant or lactating.
2) Subjects 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.
3) Medication which may affect skin response and/or past medical history.
4) Subjects having history of diabetes.
5) Subjects 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.
6) Subjects suffering from any active clinically significant skin diseases which may contraindicate.
7) Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer.
8) Participation in any patch test for irritation or sensitization within the last four weeks.
9) Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease).
10) Subjects with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
11) 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.
12) Subject with known allergy or sensitization to medical adhesives, bandages.
13) Subjects have participation in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.
14) Subject reports a history of skin sensitivity to shampoos and detergents or a known hypersensitivity and/or sensitization to medical adhesives.
15) Subjects reports use of systemic or topical antihistamines (at any site) or uses of topical drugs at patch site(s) within 72 hours prior to patch application.
16) Participation in other patches study simultaneously.
17) 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
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To determine the cumulative irritation potential of the test product
2 To determine sensitization potential of the product. |
1 Induction Phase: Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9, Visit 10 and Visit 11.
2 Induction Phase: Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9, Visit 10 and Visit 11.
Challenge Phase: Visit 14, Visit 15, visit 16 and Visit 17. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="208" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2020 |
| Date of Study Completion (India) |
22/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Induction Phase:
Patch application
will be performed at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7,
Visit 8, Visit 9, Visit 10 and Visit 11.
Patch will be
removed at Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9, Visit
10 and Visit 11.
Clinically
grading will be done at Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8,
Visit 9, Visit 10 and Visit 11.
Challenge phase:
Patch application
will be on Visit 13; patch will be removed and evaluated on Visit 14.
Clinical grading will be
carried out further on Visit 15, Visit 16 and Visit 17. |