None listed
Conditions
Interventions
Intervention1: Dishwash: 500 ml of diluted test product per hand immersion session.
Control Intervention1: Positive Control (3% SLS w/v): 500 ml of Positive control â?? per hand immersion session.
Sponsors
ITC Life Sciences Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 years (both inclusive) at the time of consent. 2) Gender: Males and Females (1:1) [equal number of male and female subjects]. 3) Females of Childbearing potential must have a negative urine pregnancy test performed on Day 1. 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 generally good health as determined by the Investigator on the basis of medical history. 6) Subjects with no known acute or chronic diseases or no adverse skin response to cosmetics, personal wash or fabric wash products 7) Subjects willing and able to participate in the study, abide by the study instructions and visit the study site on all specified visit dates. 8) Subjects must be able to understand and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subjects with dermatological condition including 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 hand and forearms that can interfere with the reading. 2) Subjects with a medical condition or under medication (Oral / Topical) that may affect skin response/ which, in the Investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk. 3) Subjects having history of diabetes or any other chronic disease/ medical condition including Asthma/ COPD (Chronic obstructive pulmonary disease)/ Eczema, Atopic dermatitis, HIV, AIDS, Systemic lupus erythematous / cancer which may contraindicate. 4) Subjects with a history of treatment of any type of cancer within the last 6 months. 5) Subjects with a history of participation in any patch test/hand immersion test for irritation or sensitization within the last four weeks. 6) Use of any: a. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to enrollment. b. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to enrollment. c. Systemic or topical corticosteroids at patch site within four (4) weeks of enrollment (steroidal nose drops and/or eye drops are permitted). d. Topical drugs used at application site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of dermal safety of test product on skin of hand and forearmsTimepoint: Before immersion on Day 1 and following each immersion on Day 1, Day 2, Day 3, Day 4 and on Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the product tolerance and dermatological safety and Adverse events as per Dermatologists and subjectsâ?? self assessmentTimepoint: On Day 1, Day 2, Day 3, Day 4 and on Day 5;Assessment of the effect of Test product on skin barrier by Tewameter® TM 300Timepoint: Before and after each immersion session on Day 01, Day 02, Day 03, Day 04 and Day 05;Assessment of the effect of test product on skin hydration by Corneometer® CM 825Timepoint: Before and after each immersion session on Day 01, Day 02, Day 03, Day 04 and Day 05;Assessment of the effect of test product on skin pH by Digital pH meterTimepoint: Before and after each immersion session on Day 01, Day 02, Day 03, Day 04 and Day 05 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed