| CTRI Number |
CTRI/2023/12/060981 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
13/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Other |
|
Public Title of Study
|
Primary Irritation Patch Test for Normal Skin. (Single Application 24 hour occlusion on normal skin) |
|
Scientific Title of Study
|
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Normal Skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B03444-TLS-C, Version: 01, Dated 29 Nov 23 . |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagirath Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825618138 |
| Fax |
|
| Email |
bhagirathrpatel1818@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Satyendra Kumar |
| Designation |
Sr. Manager- Clinical Research |
| Affiliation |
Transformative Learning Solutions Pvt Ltd. |
| Address |
301B, 302-304, 3rd floor, Veritas Business Suite,
Sec-53, Gurgaon, Haryana 122002, Gurgaon HARYANA 122002
India
Gurgaon
HARYANA
122002
India |
| Phone |
9891253516 |
| Fax |
|
| Email |
satyendra.kumar@transformative.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India |
| Transformative Learning Solutions Pvt Ltd.
301B, 302-304, 3rd floor, Veritas Business Suite,
Sec-53, Gurgaon, Haryana 122002, Gurgaon HARYANA 122002
India |
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Pvt Ltd. |
| Address |
301B, 302-304, 3rd floor, Veritas Business Suite,
Sec-53, Gurgaon, Haryana 122002, Gurgaon HARYANA 122002
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 Bhagirath Patel |
Cliantha Research |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054. Ahmedabad, Gujarat.
Ahmadabad
GUJARAT |
9825618138
bhagirathrpatel1818@gmail.com |
|
|
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 |
18 to 65 years healthy adult male & female with normal skin of varied Skin types (Oily, Dry, Normal and Combination). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bi-Phasic Face Serum (TLS2324015BA01-013) |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Body Cleanser (TLS2324016CD02-043) |
8%w/v sample solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Conditioner (TLS2324018HD02-024) |
8%w/v sample solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Face Cleanser (TLS2324016CD01-020) |
8%w/v sample solution, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Face Oil (TLS2324014DA02-006) |
Neat, 0.04mg, single dose, topical application, 24 hr |
| Intervention |
Hair Serum (TLS2324017HS01-006) |
Neat, 0.04mg, 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 |
| Intervention |
Overnight Face Mask (TLS2324019SSS01-022) |
8%w/v sample solution, 0.04mg, 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 |
| Intervention |
Shampoo (TLS2324018HD01-042) |
8%w/v sample solution, 0.04mg, single dose, topical application, 24 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent.
2) Participants with normal Fitzpatrick skin type III to V. (Human skin colour determination scale).
3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
4) Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
5) Participants are in good general health as determined by the Investigator on the basis of medical history.
6) Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
7) Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
8) Participants must be able to understand and provide written informed consent to participate in the study.
9) Participants having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1) Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos, 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) Participant with history of asthma or COPD (Chronic obstructive pulmonary
disease), diabetes and mastectomy for cancer involving removal of lymph nodes
within the past year, or treatment of any type of cancer within the last 6 months.
3) Participant suffering from any active clinically significant skin diseases which
may affect the study results.
4) Participant having history of any skin diseases including eczema, atopic dermatitis.
5) Participation in any patch test for irritation or sensitization within the last four weeks.
6) Participants taking part in another study liable to interfere with the results of this study.
7) Participants with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
8) Participants with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the Participant ineligible or places the Participant at undue risk.
9) Participant with known allergy or sensitization to medical adhesives, bandages.
10) 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 |
| To evaluate the dermatological safety of the test products by 24 Hours Patch Test Under Complete Occlusion on healthy human participants with normal skin. |
30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2024 |
| Date of Study Completion (India) |
10/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study consists of single application of sample on the upper back of
human participants, under occlusive patch for the duration of 24 hour of
exposure. After removal of patches post 24 hr. The assessment of skin reaction
needs to be evaluated subjectively using the Draize Scale 24hour removal of
patches. Follow up reactions will be done one week thereafter to confirm
recovery |