A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry and Sensitive Skin.
NCT Number: NCT06489418
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Skin|Sensitive Skin
Interventions: OTHER: Dew Restore Barrier Repair Cream
Sponsor: NovoBliss Research Pvt Ltd
Collaborators: Kayura Effects LLP
Sex: ALL
Age: ADULT
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-20
Completion Date: 2024-08-20

Summary:
A prospective, control-arm, site randomized, evaluator-blinded, single-centre, safety, and efficacy study of Test Product "Dew Restore Barrier Repair Cream" in healthy adult human subjects with dry and sensitive skin.

Primary Outcome Measures: Change in DASI Score (Dry Skin/ichthyosis area and severity index). In scoring scale 0 indicates none and 4 indicates extreme., 1. To evaluate the effectiveness of the test product in terms of change in DASI score from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in Dry Skin Score. In scoring scale 0 indicates absent and 4 indicates Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks., 2. To evaluate the effectiveness of the test product in terms of change in overall dry skin score (ODS) from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in PGA Score. In scoring scale 0 means No appearance and 7-9 means severe., 3. To evaluate the effectiveness of the test product in terms of change in PGA score from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in Skin Hydration, 4. To evaluate the effectiveness of the test product t in terms of change in skin hydration from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in Skin Barrier Function, 5. To evaluate the effectiveness of the test product in terms of change in skin barrier function from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in skin roughness, 6. To evaluate the effectiveness of the test product in terms of change in skin roughness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in skin scaliness, To evaluate the effectiveness of the test product in terms of change in skin scaliness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in skin smoothness, To evaluate the effectiveness of the test product in terms of change in skin smoothness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).|Change in skin wrinkles, To evaluate the effectiveness of the test product in terms of change in skin wrinkles from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days).
Secondary Outcome Measures: Change in desquamation index, 1. To assess the effectiveness of the test product in terms of change in desquamation index from baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)|Change in visual assessment of skin dryness. 0 means absent and 4 means very severe, 2. To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)|Change in Product Perception Questionnaire. 0 means absent and 4 means very severe, 3. To assess the effectiveness of the test product in terms of subject perception questionnaire after usage of the test product from baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)|Change in visual assessment of skin smoothness. 0 means absent and 4 means very severe, To assess the effectiveness of the test product in terms of change in visual assessment of skin smoothness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)|Change in visual assessment of skin roughness. 0 means absent and 4 means very severe, To assess the effectiveness of the test product in terms of change in visual assessment of skin roughness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)|Change in visual assessment of skin redness. 0 means absent and 4 means very severe, To assess the effectiveness of the test product in terms of change in visual assessment of skin roughness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)|Change in visual assessment of skin itchiness. 0 means absent and 4 means very severe, To assess the effectiveness of the test product in terms of change in visual assessment of skin itchiness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)|Change in visual assessment of skin scaliness. 0 means absent and 4 means very severe, To assess the effectiveness of the test product in terms of change in visual assessment of skin scaliness from the baseline before and after usage of the test product., on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days)