None listed
Conditions
Interventions
Intervention1: ORS Olive Oil Sulphate-free Replenishing Shampoo: Route of administration:
Topical mode of usage:
Products will be evaluated
through the complete
occlusion patch application for
24 hour
Sponsors
Naturelle LLC
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 an equal number of males and females). 3)Participants with normal Fitzpatrick skin types III to V (human skin color determination scale). 4)Females of childbearing potential must have a self-reported negative pregnancy test. 5)Participants without any prior history of adverse skin conditions and not on medications likely to interfere with study results. 6)Participants in good general health, as determined by the Investigator based on medical history. 7)Participants willing to maintain the test patches in designated positions for 24 hours. 8)Participants willing and able to follow study instructions, participate fully, and return for all scheduled visits. 9)Participants able to understand and provide written informed consent to participate in the study. 10)Participants willing to refrain from vigorous physical exercise during the study period and comply with all provided instructions. 11)For Sensitive Skin Study Only: Participants scoring greater than 30 in Section 2 (Sensitive vs. Resistant skin) of the modified Dr. Baumann s skin type questionnaire. Participants with sensitive skin as confirmed by the lactic acid stinging test.
Exclusion criteria
Exclusion criteria: 1)Participants with skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos), recent sunburn, open wounds, cuts, abrasions, or any dermatological condition at the test site(s) (i.e., back) that may interfere with evaluation. 2)Participants using medications that may affect skin response or with a relevant past medical history that could impact study outcomes. 3)Participants with a history of diabetes. 4)Participants with a history of mastectomy involving removal of lymph nodes within the past year, or treatment for any cancer within the last 6 months. 5)Participants suffering from any active, clinically significant skin disease that may contraindicate study participation. 6)Participants with a history of skin diseases, including eczema, atopic dermatitis, or active cancer. 7)Participants who have participated in any patch test for irritation or sensitization within the last four weeks. 8)Participants with a history of asthma or COPD (chronic obstructive pulmonary disease). 9)Use of any of the following: i. Prescribed or over-the-counter (OTC) anti-inflammatory drugs within five (5) days prior to application. ii. Antihistamines 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 prior to test product application (except permitted use such as steroidal nasal drops, if applicable). 10)Participants using topical drugs at the application site. 11)Participants with self-reported immunological disorders such as HIV, AIDS, and/or systemic lupus erythematosus. 12)Participants who have a medical condition or are taking (or have taken) medication which, in the Investigator s judgment, may place them at undue risk or interfere with study results. 13)Participants with known allergy or sensitization to medical adhesives or bandages. 14)Participants currently participating in another patch study.
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 Private Limited
Outcome results
None listed