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This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the test product in healthy adult human subjects with dry or sensitive skin.
A total of up to 32 healthy male and non-pregnant | non-lactating female with dry or sensitive skin and an age of 18-55 years will be enrolled to complete the 30 subjects of 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 enrollment 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.
Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation Visit 02 (Day 02): Evaluations, Product usage period Visit 03 (Day 15 +2 Days): Evaluations, End of the Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creanz Lotion | Experimental | Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin. Frequency: Twice a Day Route of Administration: Topical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creanz Lotion | Other | Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin. Frequency: Twice a Day Route of Administration: Topical |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin hydration | Instrumental Assessment: Corneometer CM 825 | baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in skin elasticity | Instrumental Assessment: Cutometer Dual MPA 580 | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in Dry skin area and severity index | Dermatological assessment: 0 = Absent; 4 = Severe | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in Overall Dry skin Score | Dermatological assessment: 0 = Absent; 4 = Dominated by large scales | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in skin barrier function | Instrumental Assessment: TEWAMeter TM Hex | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in skin roughness | Instrumental Assessment: VISIOSCAN VC 20 Plus | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in itchiness score | Dermatological Assessment: VAS score 0= no itch,10 = severe itch | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| change in visual assessment of skin dryness, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maheshvari N Patel | Contact | 09909013286 | dr.nayan@novobliss.in | |
| Sheetal J Khandwala | Contact | bd@novobliss.in |
| Name | Affiliation | Role |
|---|---|---|
| Nayan Patel, MBBS | NovoBliss Research Private Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt.Ltd | Ahmedabad | Gujarat | 382421 | India |
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Test Product A: Creanz Lotion Mode of Usage: Apply sufficient quantity of Creanz Nourishing Body lotion to face and body for smooth and moisturised skin.
Frequency: Twice a Day Route of Administration: Topical
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| Change in skin scaliness |
Instrumental Assessment: VISIOSCAN VC 20 Plus |
| Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in skin smoothness | Instrumental Assessment: VISIOSCAN VC 20 Plus | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in skin wrinkles | Instrumental Assessment: VISIOSCAN VC 20 Plus | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
Dermatological Assessment: 0= absent,4 = Extreme |
| Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in visual assessment of skin smoothness, | Dermatological Assessment: 0= absent,4 = severe | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in visual assessment of skin roughness, | Dermatological Assessment: 0= absent,4 = extreme | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in visual assessment of skin scaliness, | Dermatological Assessment: 0= absent,4 = extreme | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in visual assessment of skin redness, | Dermatological Assessment: 0= absent,4 = extreme | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in visual assessment of skin itchiness | Dermatological Assessment: 0= None,4 = severe | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |
| Change in product perception Questionnaire | Scoring scale: 9-point hedonic scale | Baseline before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 02, and Day 15 (+2 Days) |