None listed
Conditions
Interventions
Intervention1: Equalstwo Mosquito Bite Soother: Neat, 0.04mg, single dose, topical application, 24 hr
Control Intervention1: Negative Control: Neat, 0.9gm of Sodium Chloride in 100ml of distilled wate
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18-65 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant or non-lactating females. 3) Subjects having Phototype III to V 4) Subjects having apparently healthy skin on test area 5) Subjects for whom the investigator considers that the compliance will be correct.
Exclusion criteria
Exclusion criteria: 1) Subject who is pregnant or lactating. 2) 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) that can interfere with the reading. 3) Subjects with dermatological infection or pathology on the level of studied area. 4) Subjects with hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 5) Subjects with any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the test products for their skin irritation and skin sensitization potential by repetitive applications on the skin of human subjects.Timepoint: Diagnostic Patch Time points: 0hour and 48 hours. Induction Phase: 0 hr, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432 hours. Resting Period of 14 days. Challenge phase: 24 hours, 48 hours and 72 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed