None listed
Conditions
Interventions
Intervention1: intervention of two cosmetic formulations.: This is safety test as per the BIS 4011:2018. It is three days trial. Samples are applied at the back of the subjects in term of patches alon
Sponsors
Godrej Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Phototype III to V. Healthy skin on test area. having signed a consent form able to read and write valid id prrof. urine test negative for women.
Exclusion criteria
Exclusion criteria: 1.Pregnant/nursing mothers. 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 or hair dye). 6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 7. Chronic illness which may influence the outcome of the study. 8. 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). 9. Subjects in an exclusion period or participating in another food or cosmetic or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of skin irritation potential ( Occurence of Erythema and Oedema ) w.r.t. Investigational Products at 4th day.Timepoint: at 4th day | — |
Secondary
| Measure | Time frame |
|---|---|
| To Check Contact Hypersensitivity as per BIS 4011 : 2018 directivesTimepoint: at 4th day | — |
Countries
India
Contacts
Public ContactSAMEER P SHINDE
Sanity Lifesciences Pvt.. Ltd.
Outcome results
None listed