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| Name | Class |
|---|---|
| Green Mountain Biotech Limited | UNKNOWN |
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This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel.
Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)
There will be a total of 3 visits in the study. The subject will be instructed to visit the facility as per the below visits Visit 01 (Day 01): Screening, Enrolment and Treatment Start Phase (Week 00) Visit 02 (Day 30): Treatment Phase (Week 04) Visit 03 (Day 60): End of Study (Week 08) The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent. Subjects will be asked to not wear any makeup on the face on screening day.
Assessment of efficacy parameters before test products usage will be done on Day 01 after enrolment and after test products usage will be done on Day 30 (± 2 days) and Day 60 (± 2 days) as listed-below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Mode of Usage: Twice a day on clean skin Route of Administration: Topical application. |
|
| Anti-Ageing and Skin Brightening Gel | Experimental | Mode of Usage: Twice a day on clean skin Route of Administration: Topical application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo Comparator |
| |
| Anti-Ageing and Skin Brightening Gel |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Elasticity | To assess the effectiveness of the test products in terms of change in Skin Elasticity from "before test product usage" and "after test product usage" using Cutometer Dual MPA 580 | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
| Change in CIE L*, a* b*, ITA (Individual Topography Angle), skin brightness, skin pigmentation | To assess the effectiveness of the test products in terms of change in CIE L*, ITA angle, a* and b* from "before test product usage" and "after test product usage" using Skin Colorimeter CL 400. | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
| Change in Skin Glow | To assess the effectiveness of the test products in terms of change in Skin Glow from "before test product usage" and "after test product usage" using Skin Glossymeter GL 200. | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
| Change in crow's feet area wrinkles, fine lines | To assess the effectiveness of the test products in terms of change in crow's feet area wrinkle, fine line from "before test product usage" and "after test product usage" using Visioscan VC 20 | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
| Change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin | To assess the effectiveness of the test products in terms of change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin from "before test product usage" and "after test product usage" using Visioscan VC 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physician Global Assessment (PGA) Score | To assess the effectiveness of test treatment in terms of change in PGA scores i.e. dryness, redness, fine lines, coarse wrinkle, laxity, roughness, and sallowness by using Griffith scale Where 0= No appearance and 9= Severe | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Nayan K Patel | NovoBliss Research Private Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt Ltd | Gandhinagar | Gujarat | 382421 | India |
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| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study
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Subjects will be randomly assigned in as 1:1 ratio to receive either test product A or B.
| Other |
Anti-Ageing and Skin Brightening Gel. |
|
| From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
| Change in facial photographs | To assess the effectiveness of the test products in terms of change in facial photographs from "before test product usage" and "after test product usage" using digital photographs. | From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products |
| Change in wrinkles, fine lines and pores | To assess the effectiveness of the test products in terms of change in wrinkles, fine lines and pores from "before test product usage" and "after test product usage" using Image-pro Software. | From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products |
| Change in Level of skin photodamage | To assess the effectiveness of the test products in terms of change in level of photodamage using Glogau skin age | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
| Change in skin pigmentation | To assess the effectiveness of the test products in terms of change in skin pigmentation using skin pigmentation scoring. Scoring Scale:(0-absent, 1-mild, 2-moderate, 3-severe) | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |
| Assessment of Consumer Perception | To assess the consumer perception of the test products regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal using questionnaire. Scoring Scale: (1- strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree). | From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products |