A Clinical Study to Assess the Safety, In-use Tolerability of Test Product in Healthy Adult Subjects With Dry and Sensitive Skin.
NCT Number: NCT06489600
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Skin|Sensitive Skin
Interventions: OTHER: No Rays, Thanks Mineral sunscreen
Sponsor: NovoBliss Research Pvt Ltd
Collaborators: Kayura Effects LLP
Sex: ALL
Age: ADULT
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-20
Completion Date: 2024-08-05

Summary:
This is open-label, interventional, prospective, safety in-use tolerability study of test product "No Rays, Thanks Mineral Sunscreen" in healthy adult human subjects with dry and sensitive skin.

Primary Outcome Measures: Change in local intolerance assessment for skin irritation using 4-point scoring scale where 0 indicate absent and 3 indicate severe., To assess the safety of the test product in terms of change in local intolerance assessment for irritation by dermatological assessment, On Day 01 at T15 mins and on Day 15 (± 2 Days).|Change in local intolerance assessment for skin dryness using 4-point scoring scale where 0 indicate absent and 3 indicate severe., To assess the safety of the test product in terms of change in local intolerance assessment for dryness by dermatological assessment, On Day 01 at T15 mins and on Day 15 (± 2 Days).|Change in local intolerance assessment for skin oedema using 4-point scoring scale where 0 indicate absent and 3 indicate severe., To assess the safety of the test product in terms of change in local intolerance assessment for oedema by dermatological assessment, On Day 01 at T15 mins and on Day 15 (± 2 Days).|safety of the test product in terms of local intolerance assessment of irritation (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe., To evaluate the safety of the test product in terms of local intolerance assessment of irritation by Patient Global Assessment scale., On Day 01 at T15 mins and on Day 15 (± 2 Days).|safety of the test product in terms of local intolerance assessment of dryness (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe., To evaluate the safety of the test product in terms of local intolerance assessment of dryness by Patient Global Assessment scale., On Day 01 at T15 mins and on Day 15 (± 2 Days).|safety of the test product in terms of local intolerance assessment of oedema (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe., To evaluate the safety of the test product in terms of local intolerance assessment of oedema by Patient Global Assessment scale., On Day 01 at T15 mins and on Day 15 (± 2 Days).
Secondary Outcome Measures: where will you rank the test product in terms of appearance in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters- appearance through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of spreadibility in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters- spreadibility through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of texture in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters-texture through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of fragrance in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters-fragrance through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of absorption in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters-absorption through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of colour in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters-colour, through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of tackiness in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters-tackiness, through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of non-sticky/non-oily in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameters-non-sticky/non-oily through the subject product perception assessment., On Day 01 and after test product usage on Day 01 at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of light weight in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of change in organoleptic parameter light weight through the subject product perception assessment through the subject product perception assessment., On Day 01 after usage of test product at T15 mins, and on Day 15 (±2 Days)|where will you rank the test product in terms of satisfaction in which 1 indicate very poor and 5 indicate excellent., To assess the test product in terms of organoleptic parameter in rate in terms of satisfaction., On Day 01 after usage of test product at T15 mins, and on Day 15 (±2 Days)