None listed
Conditions
Interventions
Intervention1: Pure Origin Italian Beetroot Face Pack Powder: Neat (1:1 Slurry), 0.04mg, single dose, topical application, 24 hr
Intervention2: Pure Origin Korean Vitamin C Face Mask: Neat, 0.04mg, si
Sponsors
Honasa Consumer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent. 2) Subjects with normal Fitzpatrick skin type III to V. (Human skin colour determination scale). 3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application. 4) Subjects who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results. 5) Subjects are in good general health as determined by the Investigator on the basis of medical history. 6) Subjects willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period. 7) Subjects willing and able to follow the study directions to participate in the study, return for all specified visits. 8) Subjects must be able to understand and provide written informed consent to participate in the study. 9) Subjects having valid proof of identity and age.
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) Subject with history of asthma or COPD (Chronic obstructive pulmonary disease), diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months. 3) Subject suffering from any active clinically significant skin diseases which may affect the study results. 4) Subject having history of any skin diseases including eczema, atopic dermatitis. 5) Participation in any patch test for irritation or sensitization within the last four weeks. 6) Subjects taking part in another study liable to interfere with the results of this study. 7) Subjects with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous. 8) Subjects with a medical condition or are taking or have taken a medication which, in the Investigator s judgment, makes the subject ineligible or places the subject at undue risk. 9) Subject with known allergy or sensitization to medical adhesives, bandages. 10) 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 product application (steroids nose drops and/or eye drops are permitted). IV. Topical drugs used at application site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessment of ProductsTimepoint: 30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09) | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Parth Joshi
Cliantha Research
Outcome results
None listed