To test the safety of test product by primary irritation patch test on Sensitive Skin

Phase 4

Active, not recruiting

Conditions: Healthy Human Volunteers

Registration Number: CTRI/2023/05/053322

Lead Sponsor: Dabur India Limited

Brief Summary: Irritants are substances that provoke immediate response in the skin perceived as a superficial skin reaction in terms of erythema, oedema and/or papules. The severity of irritation depends upon the nature, concentration, and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), oedema (swelling), and vesiculation and finally, to an intense supportive reaction without the involvement of the immune system. In general, patches are applied for a contact period of 24 hours, and skin reaction is assessed under a constant artificial daylight source and the marked site is scored post 24 hours after the removal of the patches.The study will be conducted as per IS 4011:2018 Guidelines.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 24

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 numbers of males and females) 3.Subject with normal Fitzpatrick skin type III to V.
4.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ€™s skin type questionnaire.
5.Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
6.Subject will undergo â€˜lactic acid stinging testâ€™ at screening and subject with positive reaction to test will only be enrolled in the study.
7.Subject who does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
8.The subject is in good general health as determined by the Investigator based on medical history.
9.Subject willing to maintain the test patches in designated positions for 24 Hours.
10.The subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
11.Subject must be able to understand and provide written informed consent to participate in the study.
12.The subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.

Exclusion Criteria

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.
Medication which may affect skin response and/or past medical history.
Subject 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.
Subject suffering from any active clinically significant skin diseases which may contraindicate.
Participation in any patch test for irritation or sensitization within the last four weeks.
Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
Subject with Self-Reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
An 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.
Subject with known allergy or sensitization to medical adhesives, bandages.
Participation in other patch study simultaneously.
Use of any: a.
Prescribed or over the counter (OTC) anti-inflammatory drug within five (5) days prior to application.
Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted) d.
Topical drugs used at application site.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of subjects that showed No significant irritation.	Day 1, Day 2, Day 3, Day 9
2. Score of less than or equal to 2 on the Draize scale.	Day 1, Day 2, Day 3, Day 9

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1): TrialGuna Private Limited
🇮🇳
Bangalore, KARNATAKA, India
TrialGuna Private Limited
🇮🇳Bangalore, KARNATAKA, India
Dr Sohandas Shetty
Principal investigator
8867125414
drsohanshetty@yahoo.co.in