None listed
Conditions
Interventions
Intervention1: OP1 Hydrating Cream: Mode of Application: Apply the moisturizer evenly. Do not massage excessively. Allow full absorption of test product
Frequency: Single application
Route of adminis
Sponsors
Yasham Speciality Ingredients Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 years at the time of consent. 2) Sex: Healthy males and non-pregnant, non-lactating female participants. 3) Participants with skin hydration less than 30 a.u. at application site through instrumental analysis. 4) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit. 5) Participants lower leg must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, or open wounds on or near the test sites. 6) If the participant is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 7) Participants who commit not to use any product on application site during the study period. 8) Participants are not allowed to participate in any other study until this study is complete. 9) Participants are willing to give written informed consent and are willing to come for regular follow up.
Exclusion criteria
Exclusion criteria: 1) Participants with other dermatologic diseases whose presence or treatments could interfere with the assessment of study. 2) Participants that are pregnant and/or breastfeeding. 3) The participant has a known allergy or sensitivity to any cosmetic product. 4) The participant has any other skin conditions i.e. cuts, scratches, ring worms, etc.at the application site which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the participant. 5) The participant is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data. 6) History of chronic illness which may influence the cutaneous state. 7) Participants with any similar clinical study within past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test products in terms of change in skin hydration assessed within each test product and between test products. 2.To evaluate the effectiveness of the test products in terms of change in skin barrier function assessed within each test product and between test products. Timepoint: 1. baseline before application of the test products on Day 01 and after application of the test products at T30 min, T3 hours and T12 hours( 1 hour) on Day 01, T24 hours ( 1 hour) on Day 02, T48 hours ( 1 hour) on Day 03 and T100 hours ( 1 hour) on Day 05. 2. baseline before application of the test products on Day 01 and after application of the test products at T30 min, T3 hours and T12 hours( 1 hour) on Day 01, T24 hours ( 1 hour) on Day 02, T48 hours ( 1 hour) on Day 03 and T100 hours ( 1 hour) on Day 05. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of test products in terms of change in visual and tactile assessment of skin including skin scaliness, skin roughness, skin redness, skin itchiness, skin dryness and skin smoothness assessed within each test product and between test products.Timepoint: baseline before application of the test products on Day 01 and after application of the test products at T30 min, T3 hours and T12 hours( 1 hour) on Day 01, T24 hours ( 1 hour) on Day 02,T48 hours( 1 hour) on Day 03 and T100 hours ( 1 hour) on Day 05;2. To evaluate the effectiveness of test products by assessing change in Product Evaluation Questionnaire assessed within each test product and between test products.Timepoint: after application of the test products at T30 min | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed