None listed
Conditions
Interventions
Intervention1: Dermoviva hair removal cream: 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
Naturelle LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years at the time of consent. 2. Sex: males and non-pregnant or non-lactating females, where both males and females will be preferred in equal numbers. 3. Participants with normal Fitzpatrick skin types III to VI, which is the human skin colour determination scale. 4. Females with childbearing potential must have a self-reported negative pregnancy test. 5. Participants who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with results. 6. Participant is in good general health as determined by the investigator on the basis of medical history. 7. The participant is willing to maintain test patches in the designated position for 24 hours. 8. The participant is willing and able to follow the study direction to participate in the study, returning for all specified studies. 9. Participant must be able to understand and provide written informed consent to participate in the study. 10. The participant is willing to refrain from vigorous physical exercise during the study period and follow all the given study instructions. 11. For sensitive skin conditions only: a participant scoring greater than 30 for section 2, sensitive versus resistant, and participant with sensitive skin as confirmed by the lactic acid screening test.
Exclusion criteria
Exclusion criteria: 1. Participants must not be enrolled in the study if they meet any one of the following criteria: Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, and marks like tattoos within the previous 3 months, scars, sunburn, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site such as back that can interfere with the reading. 2. Medication which may affect skin response or past medical history. 3. Participant having a history of diabetes. 4. Participants have a history of mastectomy for cancer involving the removal of lymph nodes within the past year or treatment of any types of cancer within the last 6 months. 5. Participant suffering from any active clinically significant skin disease which may be contraindicated. 6. Participant having a history of any skin disease, including eczema, atopic dermatitis or active cancer. 7. Participant in any patch test for irritation or any sensitisation within the last four weeks. 8. Participant having a history of asthma or COPD. 9. Use of any prescribed or OTC inflammatory drug within five days prior to application. antihistamine medication or immunosuppressive drugs within seven days prior to first patch application and systemic or topical corticosteroids at the patch site within four weeks of test product application. In this study, nasal and eye drops are permitted. 10. Topical drug used at application site. 11. A participant with a self-reported immunological disorder, HIV positivity, AIDS, or systemic lupus erythematosus. 12. Individual who has a medical condition or is taking or has taken a medication which, in the judgement of investigator, makes the participant ineligible or places the participant at undue risk. 13. Participant with known allergy or sensitisation to medical adhesives or bandages. 14. Participation in other patch study simaltaniously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety of the test products by 24 Hours Patch Test.Timepoint: After 30 mins, 24 hrs of patch removal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the skinTimepoint: After 30 min and 24 hours of path removal | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed