None listed
Conditions
Interventions
Intervention1: Baby Wipes: Neat (1 sq. cm = drop of saline solution), topical and repetitive application
Control Intervention1: Negative Control: Neat, 0.9gm of Sodium Chloride in 100ml of distilled w
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years (both inclusive) at the time of consent. 2. Sex: Males and non-pregnant/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. 6. Subjects are in good general health as determined by the Investigator on the basis of medical history. 7. Subjects who are cooperating, are informed of the need and duration of the examinations and ready to comply with protocol procedures. 8. Subjects who have signed a Consent Form. 9. Subjects who are willing to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 10. Subjects who are willing to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna ...), during the course of the study. 11. Subjects who are able to read and write (in English, Hindi or local language). 12. Subjects having valid proof of identity and age.
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/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. 6. Subjects with Chronic illness which may influence the outcome of the study. 7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month). 8. Subjects in an exclusion period or participating in another food, cosmetic or therapeutic trial.
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 Ruchi Srivastava
Cliantha Research
Outcome results
None listed