None listed
Conditions
Interventions
Intervention1: MEE MEE 99% Pure Water Wipes: Route of administration: Topical
mode of usage: Products will be evaluated through the complete occlusion application for 24 hours. At 24hours post-applic
Sponsors
Mor Medics Science and Technologies
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 pregnancy test 5) Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 6) 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) Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given. 11) For Sensitive Specific Skin Study Only: Subject scoring greater than 30 for Section 2 Sensitive v/s Resistant skin in modified Dr Baumann s skin type questionnaire. Subject with sensitive skin as confirmed by Lactic Acid Stinging Test.
Exclusion criteria
Exclusion criteria: 1) 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. backthat can interfere with the reading. 2) Medication which may affect skin response and/or past medical history. 3) Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within thepast year, or treatment of any type of cancer within the last 6 months. 5) Subject suffering from any active clinically significant skin diseases which maycontraindicate. 6) Subject having history of any skin diseases including eczema, atopic dermatitis or activecancer. 7) Participation in any patch test for irritation or sensitization within the last four weeks. 8) Subject having 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 toapplication. ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior tofirstpatch application. iii. Systemic or topical corticosteroids at patch site within four (4) weeks of testproductapplication (steroidal nose drops and/or eye drops are permitted). 10) Topical drugs used at application site. 11) Subject with Self-reported Immunological disorders such as HIV positive, AIDSand/orsystemic lupus erythematous. 12) Individual who has a medical condition or is taking or has taken a medication which,in theInvestigator s judgment, makes the subject ineligible or places the subject atundue risk. 13) Subject with known allergy or sensitization to medical adhesives, bandages. 14) Participation in other patch study simultaneously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of the test products by 24 Hours Patch TestTimepoint: To evaluate the dermatological safety of the test products by 24 Hours Patch Test | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the skinTimepoint: At T30 minutes and 24 hours post patch removal. Scoring can be done at T168 hours post-patch removal if required. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed