None listed
Conditions
Interventions
Intervention1: Natural liquid detergent: per bucket serving 40 ml. Immersion of hands up to wrist will be done twice daily in between 4 hours gap for 4 consecutive days.
Control Intervention1: Positiv
Sponsors
Godrej Consumer Product Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age 18 to 55 years both inclusive at the time of consent 2 Sex Males and non pregnant or 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 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 is in good general 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 follow the study directions, to participate in the study, returning for all specified visits 8 Subjects must be able to understand and provide written informed consent to participate in the study
Exclusion criteria
Exclusion 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. hand and forearms of subjects 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 Participation in any patch test/hand immersion test for irritation or sensitization within the last four weeks. 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 Investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk. 11 Participation in other patch study simultaneously. 12 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin irritation potential of test detergent product on skin of hand and forearmsTimepoint: Baseline, day 1, day 2, day 3, day 4 after each immersion and Day 5 in morning after last immersion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Skin pH assessment 2 Skin hydration of both hands by Corneometer 3 Skin Moisturisation of both hands by Tewameter 4 Safety of the subject by AE assessment Timepoint: Baseline, day 1, day 2, day 3, day 4 after each immersion and Day 5 in morning after last immersion | — |
Countries
India
Contacts
Public ContactMs Maheshvari Tamboli
Cliantha Research
Outcome results
None listed