| CTRI Number |
CTRI/2023/06/054569 [Registered on: 30/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Personal care product] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation Of the Irritation and Sensitization Potential of Test Products in Healthy Adult Human Subjects |
|
Scientific Title of Study
|
Evaluation Of the Cumulative Irritation and Sensitization Potential of Test Products in Healthy Adult Human Subjects by Repeat Insult Patch Testing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/076, Dated 12 Jun 2023, version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
TrialGuna Private Limited
467, 1st Main, 4th Cross, Royal County Layout,
JP Nagar, 8th Phase, 2nd Block,
Bangalore- 560083, India
Bangalore
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
TrialGuna Private Limited
467, 1st Main, 4th Cross, Royal County Layout,
JP Nagar, 8th Phase, 2nd Block,
Bangalore- 560083, India
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO Representative |
| Affiliation |
TrialGuna Private Limited |
| Address |
TrialGuna Private Limited
#467, 1st Main, 4th Cross, Royal Country Layout, JP Nagar, 8th Phase, 2nd block, Bangalore.
Bangalore
KARNATAKA
560083
India |
| Phone |
09972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Healthy
Adult Human Subjects By Repeat Insult Patch Testing |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Makali, Bengaluru 562 162, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sohandas Shetty |
TrialGuna Private Limited |
TrialGuna Private Limited
#467, 1st Main, 4th Cross, Royal Country Layout, JP Nagar, 8th Phase, 2nd block, Bangalore.
Bangalore
KARNATAKA |
8867125414
drsohanshetty@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative control
Isotonic Saline Solution (0.9 % w/v) |
Treatment period: 20 days Route of Administration: Skin Dosage Quantity Sufficient |
| Intervention |
Test product |
Treatment period: 20 days
Route of Administration: Skin Dosage
Quantity Sufficient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult male/female subjects will be considered as potential participants in the study. Subjects must be enrolled in the study only after obtaining written informed consent.
Subject must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
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 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 toparticipate inthe study.
8) Subjects willing to refrain from vigorous physical exercise during the study period.
|
|
| ExclusionCriteria |
| Details |
Subjects must not be enrolled in the study if they meet any one of the following criteria:
1) 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.
2) Medication which may affect skin response and/or past medical history.
3) Subjects having history of diabetes.
4) 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.
5) Subjects suffering from any active clinically significant skin diseases which may
contraindicate.
6) Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer.
7) Subjects participating in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.
8) Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease).
9) Subjects 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) Subject reports a history of skin sensitivity to shampoos and detergents or a known
hypersensitivity and/or sensitization to medical adhesives.
13) 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.
14) Participation in other patch study simultaneously.
15) 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 |
Number of subjects that showed No significant irritation.
Score of less than or equal to 2 on the Draize scale |
Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 15, Day 16, Day 17, Day 18 & Day 19 |
|
|
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)= "201"
Final Enrollment numbers achieved (India)="201" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2023 |
| Date of Study Completion (India) |
26/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cosmetics are applied on the skin by most people on a daily basis. These products and
materials are potential sources of cutaneous irritation. Hence, their safety becomes very
important. Several types of tests are used widely for the evaluation of safety of cosmetics in human,
which include single patch test, in-use test, cumulative irritation patch
testing, human repeated insult patch test (HRIPT) for irritation and sensitization potential. The Modified Draize Procedure 2
is used as a predictive test for contact sensitization in
humans. The procedure involves the application of a discontinuous series of multiple
occlusive patches to human skin over a three-week induction period. Induction is followed
by rest period. Challenge consists of a single application to new skin site. The objective of this study is to evaluate the test products for the induction of contact
sensitization by repetitive applications to the skin of human volunteers. |