None listed
Conditions
Interventions
Intervention1: 1.IITB/NE/O Ointment,2. IITB/BO/O1 Body oil,3.IITB/BG/O1 Body scrub,4. IITB/NG/O1 Gel,5. IITB/NSF/O1 Body lotion: For Product 1 to 5: 40 µl which amounts to 0.040g of the net sample
Sponsors
Indian Institute of Technology Bombay
Eligibility
Inclusion criteria
Inclusion criteria: 1.Volunteer (female and male) in generally good health. 2.Volunteer between the ages of 18 and 50 years. 3.Volunteer has not participated in a similar clinical studies in the past three months. 4.Volunteer willing to give a written Informed Consent, also agrees under audio-video consenting procedures and should come for regular three visits after patch application. 5.Volunteer with fair skin will be preferred. 6.Volunteer with clear back. 7.UPT test should be negative for female volunteer at the time of screening.
Exclusion criteria
Exclusion criteria: 1.Known history or present condition of allergic response to any cosmetic products. 2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings. 3.Medications (e.g. steroids or antihistamines), which would compromise the study. 4.Under the influence of alcohol. 5.Pregnant or lactating women. 6.Any history of underlying uncontrolled medical illness including diabetes, liver disease or any other serious medical illness 7.Volunteers participating in any other cosmetics related clinical trials or any other clinical trial. 8.Hypersensitivity to any of the tested products. 9.Use of Hormonal Contraceptives either Oral or Implants. 10.Any other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Skin irritation potential (occurrence of Erythema, Oedema) w.r.t. the investigational products.Timepoint: Day 1- Screening, Day 2 Patch application, Day 3 - Patch removal(0 hr observation), Day 4- 24hr Observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Sudhir Medhekar
Sanity Lifesciences Pvt.Ltd
Outcome results
None listed