| CTRI Number |
CTRI/2023/06/053595 [Registered on: 06/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Primary Irritation Patch Testing] |
| Study Design |
Other |
|
Public Title of Study
|
To Check Dermatological Safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete
Occlusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NBSP23-PIPT-0009-DE Version 01 28Sep22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
Gandhinagar
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat - India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj, Gandhinagar,Gujarat - India
Gandhinagar
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| DPKA Universal Consumer Venture Private Limited |82°E
Beau Monde, 3002, Tower-B,
30th Floor New Prabha Devi Road,
Prabha Devi Mumbai 400025, India |
|
|
Primary Sponsor
|
| Name |
DPKA Universal Consumer Venture Private Limited |82°E |
| Address |
Beau Monde, 3002, Tower-B,
30th Floor New Prabha Devi Road,
Prabha Devi Mumbai 400025, India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Nayan Patel |
NovoBliss Research Pvt. Limited |
Office-A - 206, 2nd
Floor, Shaligram
Lakeview, Nr.
Vaishnodevi Circle,
Khoraj, Gandhinagar –
382421
Gandhinagar
GUJARAT |
9909013286
dr.nayan@novobliss.in |
|
|
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 |
Adequate representation of varied skin types |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clay Mask |
Dose: 0.04mL Route of
administration: Topical Products
will be evaluated through the
complete occlusion or open
application for 24 hours. At 24
hours post-application, patches
will be removed and skin will be
evaluated for irritation reactions
at 30 mins,24 hours (Day 1)
post patch removal and 168
hours (Day 7) post-patch
removal (if needed). |
| Comparator Agent |
Negative Control - Sodium
chloride (Isotonic Saline
Solution) Injection IP 0.9 % w/v |
Dose: 0.04mL Route of
administration: Topical Products will be evaluated through the complete occlusion or semi occlusion application for 24 hours. At 24hours
post-application, patches will be removed and skin will be
evaluated for irritation reactions at 30 mins, 24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch
removal (if needed). |
| Comparator Agent |
Positive Control - 1% w/v Sodium Lauryl Sulphate (SLS) analytical grade |
Products will be evaluated through the complete occlusion or semi occlusion application for 24 hours. At 24hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins, 24 hours (Day 1) post patch removal and 168 hours (Day 7) post-patch removal (if needed). |
|
|
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 01 prior to patch
application.
5. Subject who do not have any previous history of
adverse skin conditions and are not under any medication likely to
interfere with the results.
6. The subject is in good general
health as
determined by the Investigator on the basis of
medical history.
7. Subjects are willing to maintain the test
patches in designated positions for 24 Hours.
8. Subject is
willing and able to follow the study directions, to participate in the
study, returning for all specified visits.
9. The subject must be
able to understand and provide written informed consent to
participate in the study.
10. Subject is willing to refrain from
vigorous physical exercise during the study period and
follow all
the instructions 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. 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)
10. Topical drugs used at application site.
11. Subject with Self-reported Immunological disorders such as HIV
positive, AIDS and/or systemic lupus erythematous.
12. 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.
13. Subject with known allergy or sensitization to medical adhesives,
bandages.
14. Participation in other patch study simultaneously. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the dermatological safety of the test
products by 24 Hours Patch Test Under
Complete Occlusion on healthy adult human
subjects & adequate representation of varied
skin types (Oily, Dry, Normal & Combination).
|
30 mins, 24 Hour & 168 hour (if needed). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the skin |
At 30 mins & 24 hours post patch removal.
Scoring can be done at 168 hours post-patch
removal if needed |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2023 |
| Date of Study Completion (India) |
20/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
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)?
Response - NO
|
|
Brief Summary
|
This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion | semi occlusion | open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 completed the study.
There are total three visits in this study and are optional visit
Pre-screening visit : Lactic Acid Stinging test& Modified Dr baumenn’s skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01).
Visit 02: Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal.
Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site.
Follow-up visit for reactions if any to confirm recovery (optional deemed necessary).
Irritation scoring at 168 ± 2 hours post-patch removal (Day 09) |