None listed
Conditions
Interventions
Intervention1: Cosmetic Marketed Cream,
Cosmetic Marketed Skin Moisturising Lotion: At 30 mins, 24 hours and 168 hours post patch removal
Control Intervention1: Positive Control-Sodium Lauryal Sulphat
Sponsors
NovoBliss Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years (both inclusive) at the time of consent. 2. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). 3. Subject with normal Fitzpatrick skin type III to V (human skin colour determination scale). 4. Females of childbearing potential must have a self-reported negative urine pregnancy test before patch application. 5. Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 6. The subject is in good general health as determined by the Investigator on the basis of medical history. 7. Subjects is willing to maintain the test patches in designated positions for 24 Hours. 8. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 9. Subject must be able to understand and provide written informed consent to participate in the study. 10.The subject is willing to refrain from vigorous physical exercise during the study period and follow all the instructions given
Exclusion criteria
Exclusion criteria: 1. A subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, 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. Medication that may affect skin response and/or past medical history. 3. A subject having a history of diabetes 4. The subject has a 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. 5. A subject suffering from any active clinically significant skin diseases which may contraindicate. 6. A subject has a history of any skin diseases including eczema, atopic dermatitis or active cancer. 7. Participation in any patch test for irritation or sensitization within the last four weeks. 8. A subject has a history of asthma or COPD (Chronic obstructive pulmonary disease). 9. Use of any: i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application. ii.Ã? Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application. iii. Systemic or topical corticosteroids at patch site within four weeks of test product application (steroidal nose drops and/or eye drops are permitted) 10. Topical drugs used at the application site. 11. Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus. 12. An individual who has a medical condition or is taking or has taken a medication which, in the Investigatorââ?¬•s judgment, makes the subject ineligible or places the subject at undue risk. 13. Subject with known allergy or sensitization to medical adhesives, bandages. 14. Participation in other patch studies simultaneously
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the controls and evaluations techniques that are used during the conduct of Primary Irritation Patch Test (PIPT) studies at by NovoBliss Research by 24 Hours Patch Test Under Complete Occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination).Timepoint: At 30 mins, 24 hours and 168 hours post-patch removal | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the SubjectsTimepoint: Irritation Scoring at 30 mins, 24 hours and 168 hours post-patch removal | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed