None listed
Conditions
Interventions
Intervention1: ZEROZERO HAIR REMOVAL SPRAY: Dose: 0.04 ml
Route of administration: Topical
Mode of usage: Products will be evaluated after 24 hours post-application, patches will be removed and skin
Sponsors
Smart Laboratories 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) Subject with normal Fitzpatrick skin type III to VI (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 in 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 give 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 sunbcuts,abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that reading. 2) Medication which may affect skin response or past medical history. 3) Subject having history of diabetes 4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year. 5) Subject suffering from any active clinically significant skin diseases which may contraindicate. 6) Subject having 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) Subject having history of asthma or COPD (Chronic obstructive pulmonary disease). 9) Use of any medication as below, 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 (steroidal nose drops and/ 10) Topical drugs used at application site. 11) Subject with Self-reported Immunological disorders such as HIV positive, AIDS or systemic lupus erythematous. 12) Individual who has a medical condition or is taking or has taken a medication which, in the Investigator s judgment. 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 product by 24 Hours Patch Test Under short duration open patchTimepoint: After 30 minutes, 24 hours of patch removal | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of skinTimepoint: After 30 minutes, 24 hours of patch removal | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed