None listed
Conditions
Interventions
Intervention1: Baby massage oil (DRDC/2026/007): 40 ul of the product will be applied to the participants back with no dilution on Visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 13 and 17.
Control Intervention1:
Sponsors
Dabur Research Development Centre Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male & female participants in the age group 18 - 65 years (both ages inclusive). 2. Trial participants must be generally in good health as determined from a recent medical history which is on file with the investigator. 3. The ability of the trial participant to understand and sign a written informed consent form which must be obtained prior to treatment. 4. Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study. 5. Trial participants must have clear back. They should not have any infection or allergy in the tested area. They should have healthy skin in the test area 6. Trial participants should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures 7. Trial participants having valid proof of identity and age. 8. Willingness to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study
Exclusion criteria
Exclusion criteria: 1. Pregnant women/ Nursing mothers (self-declared) 2. Scars or excessive terminal hair on the study area. 3. Tattoo on the study area. 4. Henna tattoo anywhere on the body (in case of studies involving hair dyes). 5. Dermatological infection/pathology on the level of the study area 6. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 7. Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures 8. Chronic illness which may influence the outcome of the study. 9. Trial participant 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) 10. Trial participant in an exclusion period or participating in another food, cosmetic or therapeutic trial. 11. Trial participants having mole or hair on the back which may influence the study results as per the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the sensitization potential of the product To determine the cumulative irritation potential of the test product by 9 occlusive applications.Timepoint: Visit 12, Visit 16, Visit 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed