Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Glowderma Lab Private Limited | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is an exploratory, prospective, open-label, interventional, safety in-use, tolerability and efficacy study of the test product "Moiz Cleansing Lotion" in healthy human subjects.
27 subjects with different skin type (dry/ oily/ sensitive/ mixed/) of either gender aged between 18 to 65 years old (both inclusive) at time consent will be enrolled to complete 25 subjects/test product in 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-
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry, sensitive, oily, mixed, normal skin type | Experimental | Test Product Name: Moiz Cleansing Lotion Product By: Glowderma Lab Private Limited Mode of Usage: Apply 5-10 ml of Moiz Cleansing Lotion to wet skin. Massage gently for 1-2 minutes, then rinse and pat dry. Frequency: Twice a Day Route of Administration: Topical. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moiz Cleansing Lotion | Other | Mode of Usage: Apply 5-10 ml of Moiz Cleansing Lotion to wet skin. Massage gently for 1-2 minutes, then rinse and pat dry. Frequency: Twice a Day Route of Administration: Topical. |
| Measure | Description | Time Frame |
|---|---|---|
| change in L*, a*, b* value by using Skin Colorimeter | To evaluate the effectiveness of the test product in terms of change in L*, a*, b* | before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in skin impurities using Visiopor® PP34N | To evaluate the effectiveness of the test product in terms of change in skin impurities | before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30. |
| Measure | Description | Time Frame |
|---|---|---|
| change in skin hydration using Corneometer CM 825 | To evaluate the effectiveness of the test product in terms of change in skin hydration | before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in skin barrier function using TEWAMeter |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the effectiveness of the test product in terms of change in skin barrier function |
| before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in overall dry skin score by dermatological evaluations | To evaluate the effectiveness of the test product in terms of change in overall dry skin score where, 0: means absent and 4 means: Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks | before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in PGA score by dermatological evaluations | To evaluate the effectiveness of the test product in terms of change in PGA score where 0 means: No appearance and 8 means: Severe | before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in product perception questionnaire | 6. To evaluate the effectiveness of the test product in terms of change in product perception questionnaire where 0 means: Dislike extremely and 9 means liked extremly | before usage of the test product on Day 01 and after usage of the test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in visual and tactile assessment of scaliness | To evaluate the effectiveness of the test product in terms of change in scaliness where 0 means: Absent and 4 means: Extreme | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in visual and tactile assessment of roughness | To evaluate the effectiveness of the test product in terms of change in roughness where 0 means: Absent and 4 means: Extreme | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in visual and tactile assessment of redness | To evaluate the effectiveness of the test product in terms of change in redness where 0 means: Absent and 4 means: Extreme | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in visual and tactile assessment of itchiness | To evaluate the effectiveness of the test product in terms of change in itchiness where 0 means: None and 4 means: Severe | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in visual and tactile assessment of dryness | To evaluate the effectiveness of the test product in terms of change in dryness where 0 means: No Skin Dryness and 4 means: Extreme Xerosis | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in visual and tactile assessment of smoothness | To evaluate the effectiveness of the test product in terms of change in smoothness where 0 means: Very rough and 4 means: Very smooth | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in skin irritation | Safety of test product will be evaluated in terms of change in skin irritation by dermatological assessment | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in dryness | Safety of test product will be evaluated in terms of change in dryness by dermatological assessment | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in breakouts | Safety of test product will be evaluated in terms of change in breakouts by dermatological assessment | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |
| change in allergic reactions | Safety of test product will be evaluated in terms of change in allergical reactions by dermatological assessment | before usage of test product on Day 01 and after usage of test product at T20 minutes on Day 01, Day 15 and Day 30. |