None listed
Conditions
Interventions
Control Intervention1: Baby Body Lotion, Baby Cream. Baby Shampoo, Baby Body Massage Oil, Baby Hair Oil, Baby Diaper Rash Cream, Baby Talcum Powder: Dosage form: Semi Solid
Direction: For external use
Sponsors
ASCLEPIUS WELLNESS PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in age group 18 - 55 years (both the ages inclusive). 2. Healthy male and female subjects. 3. Subjects with Fitzpatrick skin type III to V. 4. Subjects willing to give a written informed consent. 5. Subjects willing to maintain the patch test in position for 24 hours. 6. Willingness to avoid to contact water during course of study. 7. Subject having not participated in a similar investigation in the past one month. 8. Subjects willing to come for regular follow up visits. 9. Subjects ready to follow instructions during the study period. 10. Willingness to avoid intense UV exposure on test site ( sun or artificial UV), during the course of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects having known hypersensitivity to the study product or its constituents. 2. Subjects having clinically significant active dermatitis or skin disease(s) anywhere in the body. 3. Athletes and subjects with history of excessive sweating. 4. Cutaneous disease which may influence the study result. 5. Subjects on oral corticosteroid . 6. Subjects participating in any other cosmetic or therapeutic study. 7. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 8. Pregnant and lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of investigational productTimepoint: Day 0 to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess any adverse drug reactionTimepoint: Day 0 to Day 7 | — |
Countries
India
Contacts
Public ContactDrAshok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed