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| Name | Class |
|---|---|
| Kayura Effects LLP | UNKNOWN |
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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.
A total of 27 Subjects will be enrolled to complete 25 Subjects the study. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult female subjects will be instructed to visit the facility as per the below visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry and Sensitive Skin | Experimental | Wash the face with the gentle cleanser to remove dirt, and oil and pat dry with the towel| tissue paper. Afterwards take the pea side amount of the test product you finger tips, apply it over the face by small dotes and massage it in circular motion until it absorbed. |
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| Control | No Intervention | Wash the application site with warm water and pat dry with towel| tissue paper. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dew Restore Barrier Repair Cream | Other | Wash the face with the gentle cleanser to remove dirt, and oil and pat dry with the towel| tissue paper. Afterwards take the pea side amount of the test product you finger tips, apply it over the face by small dotes and massage it in circular motion until it absorbed. Frequency: Twice a Day Route of Administration: Topical |
| Measure | Description | Time Frame |
|---|---|---|
| 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 minutes 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 minutes 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 minutes 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 minutes 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Nayan K Patel | NovoBliss Research Pvt Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt.Ltd | Ahmedabad | Gujarat | 382481 | India |
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A prospective, control-arm, site randomized, evaluator-blinded, single-centre, safety, and efficacy study.
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| on Day 01 and after usage of the test product at T20 minutes 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 minutes 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 minutes 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 minutes 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 minutes 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 minutes 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 minutes 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 minutes 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 minutes 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 minutes 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 minutes 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 minutes on Day 01, Day 02 [post 24 (+2) hours of the application], Day 15 (+2 Days) and Day 30 (+2 Days) |