None listed
Conditions
Interventions
Intervention1: Nappy Rash Cream: 0.04 gm of cream would be applied once with complete occlusion for 24 hours.
Control Intervention1: Negative Control - Isotonic Saline: 0.04ml would be applied once wi
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Voluntary men and women (preferably equal number of males and females) between 18 and 65 years, having sensitive skin in nasolabial area, as determined by lactic acid sting test. 2 Photo type III to V. 3 Having apparently healthy skin on test area. 4 For whom the Investigator considers that the compliance will be correct. 5 Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6 Having signed a Consent Form. 7 Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 8 Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study. 9 Should be able to read and write (in English, Hindi or local language). 10 Having any valid proof of identity and age.
Exclusion criteria
Exclusion criteria: 1 Pregnancy (by history) and lactating women. 2 Scars, excessive terminal hair or tattoo on the studied area. 3 Henna tattoo anywhere on the body (in case of studies involving hair dyes). 4 Dermatological infection/pathology on the level of studied area. 5 Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 6 Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. 7 Chronic illness which may influence the outcome of the study. 8 Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month). 9 Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.Timepoint: Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale for 24 hours after the removal of the patches or 24 h after product contact in the case of open patches | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse EventTimepoint: Adverse Event(throughout the study). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld Private Limited
Outcome results
None listed