To assess the safety of Test Products by 24 Hours Patch Test under Complete Occlusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects.

Not Applicable

Completed

• Registration Number: CTRI/2023/03/050582
• Lead Sponsor: Bankai Agrifood Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-23
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

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.

Exclusion Criteria

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 Investigatorâ??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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified