None listed
Conditions
Interventions
Intervention1: Pure Wipes: 40 µl of investigational product (without dilution) was applied on the precut filter paper placed inside the allotted Derma proof Aluminium Finn chamber prefixed to a scanpo
Sponsors
Pure Born Family Care
Eligibility
Inclusion criteria
Inclusion criteria: • Voluntary men or women between 18 and 65 years. • Photo type III to V. • Self-declaration of subject with sensitive skin. • Having apparently healthy skin on test area. • For whom the investigator considers that the compliance will be correct. • Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures. • Having signed a Consent Form. • Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. • Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna…), during the course of the study. • Should be able to read and write (in English, Hindi or local language). • Having valid proof of identity and age.
Exclusion criteria
Exclusion criteria: • Pregnant or nursing mothers • Scars, excessive terminal hair or tattoo on the studied area. • Henna tattoo anywhere on the body (in case of studies involving hair dyes). • Dermatological infection/pathology on the level of studied area. • Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye). • Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. • Chronic illness which may influence the outcome of the study. • Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). • Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the irritation & or sensitization potential of a test material. 2. In support of sensitive skin claims & supporting evidence for hypo allergenicity claims after repeated application under occlusive or semi occlusive patches to the skin of human subjects.Timepoint: Day 1 to Day 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence & rate of adverse events.Timepoint: Day 1 to Day 40 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed