None listed
Conditions
Interventions
Intervention1: DRDC/2024/038: Neat, 0.04mg, single dose, topical application, 24 hr
Control Intervention1: Negative Control: Neat, 0.9gm of Sodium Chloride
in 100ml of distilled water (0.9% w/v) , 0.0
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary man or women (preferably equal number of males and females) between 18 and 65 years with sensitive skin 2. Fitzpatrick 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 excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the course of the study. 9. Should be able to read and write (in English, Hindi or local language). 10. Having valid proof of identity and age. 11. Subject having not participated in another trial in the past one month
Exclusion criteria
Exclusion criteria: 1. Pregnant or 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 or 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 |
|---|---|
| Change in Skin Irritation Score-erythema & oedemaTimepoint: Day 0, Day 2(24 hours post patch removal), Day 8 (1 week post patch removal) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Ruchi Srivastava
CCFT Laboratories Pvt Ltd
Outcome results
None listed