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. * PGA scoring using Griffiths scale - skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness. * Glogau skin age. * Skin pigmentation scoring. * Skin elasticity: Cutometer Dual MPA 580. * Skin colorimeter CL 400: CIE L\*, a\* b\*, ITA angle, skin brightness, skin pigmentation reduction. * Skin Glossymeter GL200 - skin glow. * Visioscan (C+K instrument): crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness. * Digital photographs: facial photographs before test products usage on day 1 and post-usage at day 60. * Image-pro software - image analysis day 01 vs day 60 - wrinkles, fine lines, pores. * Subjective product perception assessment regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Placebo Comparator
Anti-Ageing and Skin Brightening Gel.
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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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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.
Time frame: 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.
Time frame: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
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
Time frame: 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 Level of skin photodamage
To assess the effectiveness of the test products in terms of change in level of photodamage using Glogau skin age
Time frame: 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)
Time frame: 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).
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products