None listed
Conditions
Interventions
None listed
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who meet all of the following criteria will be included in the study: 2.Age: 18-65 years (both inclusive) at the time of consent. 3.Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females). 4.Subject with normal Fitzpatrick skin type III to V. 5.Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects that showed No significant irritation. Score of less than or equal to 2 on the Draize scale.Timepoint: Visit 1,2,3,4,5 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactMeena Dalal
Trial Guna Pvt Ltd
Outcome results
None listed