None listed
Conditions
Interventions
Intervention1: Velona Venus Sanitary Napkin: Route of administration: Topical mode of usage: Products will be evaluated through the complete occlusion patch application for 24 hours. At 24hours post-a
Sponsors
Velona Cuddles (Pvt) Ltd
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) Participant 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) Participant who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results. 6) Participant is in good general health as determined by the Investigator on the basis of medical history. 7) Participant is willing to maintain the test patches in designated positions for 24 Hours. 8) Participant is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 9) Participant must be able to understand and provide written informed consent to participate in the study. 10) Participant 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: • Participant scoring greater than 30 for Section 2 â?? Sensitive v/s Resistant skin in modified Dr Baumannâ??s skin type questionnaire. • Participant with sensitive skin as confirmed by Lactic Acid Stinging Test.
Exclusion criteria
Exclusion criteria: 1) Participant having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos within the previous period, sunburn), open wounds, cuts, abrasions, irritation symptoms, or any dermatological condition on the test site(s), i.e., back area. 2) Participant taking medication which may affect skin response and/or having relevant past medical history. 3) Participant having a history of diabetes. 4) Participant having a history of mastectomy for cancer involving removal of lymph nodes within the past year, or any cancer treatment within the last 6 months. 5) Participant suffering from any active clinically significant skin disease which may contraindicate participation. 6) Participant having a history of any skin diseases including eczema, atopic dermatitis, or active cancer. 7) Participant who has participated in any patch test for irritation or sensitization within the last four weeks. 8) Participant having a history of asthma or COPD (Chronic Obstructive Pulmonary Disease). 9) Use of any: i. Prescribed or over-the-counter (OTC) anti-inflammatory drugs 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 the patch site within four (4) weeks of test product application (steroidal nose drops and/or inhalers permitted). 10) Participant using topical drugs at the application site. 11) Participant with self-reported immunological disorders such as HIV positive, AIDS, and/or systemic lupus erythematosus. 12) Individual who has a medical condition or is taking or has taken medication which, in the Investigatorâ??s judgment, places the participant at undue risk. 13) Participant with known allergy or sensitization to medical adhesives or bandages. 14) Participant participating in another patch study simultaneously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of the test products by 24 Hours Patch TestTimepoint: After 30 mins, 24 hrs of patch removal | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the skinTimepoint: After 30 mins, 24 hrs of patch removal | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed