Evaluation Of the Irritation and Sensitization Potential of Test Products in Healthy Adult Human Subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 201

Inclusion Criteria

Healthy adult male/female subjects will be considered as potential participants in the study. Subjects must be enrolled in the study only after obtaining written informed consent.

Subject must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.

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 toparticipate inthe study.

8) Subjects willing to refrain from vigorous physical exercise during the study period.

Exclusion Criteria

Subjects must not be enrolled in the study if they meet any one of the following criteria:

1) Subjects 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) Subjects 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.

5) Subjects suffering from any active clinically significant skin diseases which may

contraindicate.

6) Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer.

7) Subjects participating in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.

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) Subject reports a history of skin sensitivity to shampoos and detergents or a known

hypersensitivity and/or sensitization to medical adhesives.

13) 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.

14) Participation in other patch study simultaneously.

15) 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of subjects that showed No significant irritation. <br/ ><br>Score of less than or equal to 2 on the Draize scaleTimepoint: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 15, Day 16, Day 17, Day 18 & Day 19

Secondary Outcome Measures