None listed
Conditions
Interventions
Intervention1: Skin Leave-On: Neat, 0.04 ml, single dose, topical application for 24 hrs
Intervention2: Skin Leave-On: Neat, 0.04 ml, single dose, topical application for 24 hrs
Intervention3: Skin Le
Sponsors
ITC Life Sciences & Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects in the age group of 18-65 years (both inclusive) at the time of consent. 2) Subjects with Fitzpatrick skin type III to V. 3) Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females). 4) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application. 5) Subjects willing to give a written informed consent and come for regular follow up. 6) Subjects scoring greater than 30 for Section 2- Sensitive versus Resistant skin in modified Dr. Baumannâ??s skin type questionnaire. 7) Subjects identified to have sensitive skin on the basis of Dermatological assessment of skin with fine texture and closeness of blood vessels to the surface. 8) Subjects who does not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 9) Subjects in good general health as determined by the Investigator on the basis of medical history. 10) Subject willing to maintain the test patches in designated positions for 24 Hours. 11) Subjects willing and able to follow the study directions, to participate in the study, returning for all specified visits. 12) Subjects must be able to understand and provide written informed consent to participate in the study. 13) Subjects willing to refrain from vigorous physical exercise during the study period. 14) Subjects who have not participated in a similar investigation in the past eight weeks.
Exclusion criteria
Exclusion criteria: 1) Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars and sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e., back that can interfere with the reading. 2) Subjects who are pregnant or nursing (as confirmed by Urine Pregnancy Test for the determination of Pregnancy). 3) Subjects under chronic medication (e.g., Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study. 4) Subjects with cutaneous disease, chronic illness or self-reported Immunological disorders or any other illness including Diabetes, liver disease, HIV or any other serious medical illness. 5) Subjects with 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) Subjects having history of any skin diseases including eczema, atopic dermatitis etc. 8) Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease). 9) Subjects who have a medical condition or are taking or have taken a medication which, in the Investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk. 10) Subjects with known allergy or sensitization to medical adhesives, bandages or a present condition of allergic response to any cosmetic product. 11) Subjects participating in other cosmetic or therapeutic trial simultaneously. 12) Use of any: i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application. ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application. iii. Systemic or topical corticosteroids at patch site within four (4) weeks of test article application (steroids nose drops and/or eye drops are permitted). iv. Topical drugs used at application site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritation Potential of test productsTimepoint: 24 hours post patch removal (Day 03) | — |
Secondary
| Measure | Time frame |
|---|---|
| Irritation Potential of test productsTimepoint: 30 minutes post patch removal (Day 02) and 168 hours post patch removal (Day 09);Irritation potential of the test products by Subject Self-assessment (Irritation)Timepoint: Day 01, Day 02, Day 03 & Day 09;Safety by asking well-being of subject and Adverse Event assessmentTimepoint: Day 02, Day 03 & Day 09 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed