| CTRI Number |
CTRI/2024/04/065893 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Human Repeat Insult Patch Test study] |
| Study Design |
Other |
|
Public Title of Study
|
Human Repeat Insult Patch Test Study for evaluation of irritation and sensitisation |
|
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 |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NB240021-ZL, Ver (2.0), 01Apr24 |
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 |
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram
Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
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 |
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram
Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
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 |
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram
Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Limited Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382 481, India |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Limited |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad –
382 481, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
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 |
NovoBliss Research Pvt. Limited |
Clinical Trial
department, A - 206,
2nd Floor, Shaligram
Lakeview Business
Complex, Nr.
Vaishnodevi Circle,
Khoraj, Gandhinagar –
382421, Gujarat – India
Gandhinagar
GUJARAT
Gandhinagar
GUJARAT
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 |
Having good general health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% w/v isotonic saline solution |
Dose: 0.04mL
Dosage form: Saline Solution
duration: 6 weeks (42 days)
Route of administration: topical
Mode of usage: A 0.04 mL of normal saline will be applied on the back of subjects i.e. between the scapula and waist through a Finn chamber patch or equivalent.
|
| Intervention |
1.Equals Two Baby Moisturizing Body Lotion
2. Equals Two Baby Wash Gel
3. Equals Two Baby Cleansing Bar
4. Equals Two Mosquito Bite Soother |
Dose: 0.04mL
Dosage Form: Lotion
Duration: 6 weeks (42 days)
Route of administration: topical
Mode of usage: A 0.04 mL/g of test product(s) along with negative controls will be applied on the back of subjects i.e. between the scapula and waist through a Finn chamber patch or equivalent
|
|
|
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 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 take bath using the same soap/cleansers during the study period.
9) Subjects willing to refrain from vigorous physical exercise during the study period |
|
| 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) 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) Subjects has participation in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.
13) Subject reports a history of skin sensitivity to shampoos and detergents or a known hypersensitivity and/or sensitization to medical adhesives.
14) 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.
15) Participation in other patch study simultaneously.
16) 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
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the test product(s) for the induction of cumulative irritation and contact sensitization by repetitive applications to the skin of human volunteers and to report any irritation observed with the test products
induction phase:
1)To confirm that the test products are irritating or not when applied over a continuous 21-day period.
2) To evaluate the safety of test products
Challenge phase
1)To evaluate the incidence of potential sensitization reactions observed for the test products.
2) To evaluate the safety of test products
Rechallenge phase
1) To evaluate the potential sensitization reaction of the test product if observed in challenge phase. |
After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2024 |
| Date of Study Completion (India) |
11/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
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
|
This is single-center, evaluator-blinded, skin irritation and sensitization study in healthy adult human subjects using repeat insult patch testing. Study can be conducted in multiple groups. Duration will be approximately 6 weeks which includes an Induction phase (19 days) and Challenge phase (6 days) Visit 01 : Screening Visit 02 (Day 01): Induction Phase, Patch application Visit 03, 05, 07, 09, 11, 13, 15, 17, 19 (Day 02, 04, 06, 08, 10, 12, 14, 16, 18 respectively): Patch removalVisit 04, 06, 08, 10, 12, 14, 16, 18, and 20 (Day 03, 05, 07, 09, 11, 13, 15, 17, and 19): Irritation scoring and patch application. On day 19 only irritation scoring will be performed. Rest Phase: Day 20 to Day 35 Visit 21 (Day 36): Challenge Patch Application Visit 22 (Day 37): Challenge patch removal Visit 23 (Day 38): Irritation scoring (24 ± 2hrs) Visit 24 (Day 39): Irritation scoring (48 ± 2hrs) Visit 25 (Day 40): Irritation scoring (72± 2hrs) Visit 26 (Day 42): Irritation Scoring ((120± 2hr, optional visit for subjects safety) |