None listed
Conditions
Interventions
Intervention1: cosmetic ingredient: Hair dye ingredient-Ethylene Glycol Dimaleate (A): Subjects will be exposed to a 24 2 hour dermal application of the experimental investigational product during i
Sponsors
Godrej Consumer Products Limited
Eligibility
Inclusion criteria
Inclusion criteria: No active dermatological conditions Good general and mental health with in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination Subjects who have intact skin on the proposed application site dorsum (scapular region) Fitzpatrick photo type I to IV skin type Willing and able to provide informed consent after understanding the study procedures and risks
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. Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trained evaluator assessment of product tolerability through Draize scale (Dermal response) on Day 2Timepoint: Day 1, Day 2, Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of Adverse EventsTimepoint: Day 1, Day 2, Day 3 | — |
Countries
India
Contacts
Public ContactDr Shiv Poojan
Biotox Solution Private Limited
Outcome results
None listed