None listed
Conditions
Interventions
Intervention1: 1. Feminine Intimate Hygiene Wash (Batch no. FTB-PC)
2. Feminine Intimate Hygiene Wash (Batch no. FTB-FV)
3. Feminine Intimate Hygiene Wash (Batch no. FTB-FVF)
4. Feminine Intimate Hygi
Sponsors
ITC Life Sciences Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects in the age group of 18-65 years (both age inclusive). 2. Subjects with Fitzpatrick skin type III to V. 3. Subjects with good general health as determined by the Investigator on the basis of medical history. 4. Subjects who score greater than 30 for section 2 sensitive vs resistant skin in Dr. Baumanns questionnaire. 5. Subject who identified to have skin basis Dermatologists assessment of skin with fine texture and closeness of blood vessels to the surface. 6. Subjects willing to give a voluntary written informed consent. 7. Subjects willing to maintain the test patches in designated positions for 24 Hours. 8. Subjects having not participated in a similar investigation in the past eight weeks. 9. Subjects willing to come for regular follow up visits. 10. Subjects ready to follow instructions during the study period. 11. Subjects without any open wounds, cuts, abrasions, irritation symptoms. Note: 1. Dr. Baumanns questionnaire:- Subjects will need to fill for section 2: sensitive vs resistant skin in the Dr. Baumanns questionnaire and those subjects who score higher than 30 will be classified as having Sensitive skin. 2. Dermats assessment of sensitive skin:- Subjects identified to have fine textured skin and blood vessels close to superficial skin layer will be classified as having Sensitive skin.
Exclusion criteria
Exclusion criteria: 1. Female subject is pregnant, planning for pregnancy, or lactating. 2. Subject having skin irritation, pigmentation, pimple, excessive hair, mole, blemishes, marks (e.g. tattoos, scars, sunburn), or any dermatological condition that can interfere with the reading on test sites. 3. Medication which may affect skin response and/or past medical history. 4. Subject having history of diabetes. 5. Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months. 6. Subject suffering from any active clinically significant skin diseases which may contraindicate. 7. Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer. 8. Participation in any patch test for irritation or sensitization within the last four weeks. 9. Subject having history of Bronchial Asthma. 10. Subject with Self-reported Immunological disorders such as HIV, AIDS and systemic lupus erythematous. 11. Individual who has a medical condition or is taking or has taken a medication which, in the Investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk. 12. Subject with known allergy or sensitization to medical adhesives, bandages. 13. Participation in other patch study simultaneously. 14. Use of any: a. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to enrolment in the current study. b. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application. c. Systemic or topical corticosteroids at patch site within four (4) weeks of investigational product application (steroids nose drops and/or eye drops are permitted) d. Topical drugs used at application site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Dermatologists Visual Assessment of test site for Irritation. 2) Subjectsâ?? Self â?? Assessment of test site for Irritation. 3) Instrumental Measurements- measuring erythema using Mexameter and change in skin colour using Chromameter.Timepoint: 1) Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. 2) Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. 3) Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed