This is a randomized, double-blinded, single-centre, two-arms, placebo-controlled, prospective study to evaluate clinical safety, efficacy and in-use tolerability of Test Product i.e. Oziva Bioactive Gluta Fizzy Effervescent tablets in subjects with facial hyperpigmentation and dark spots.
A total of 60 Indian Subjects (30 Subjects per Test Product), including males and non-pregnant, non-lactating females aged between 21 and 55 years (inclusive). Indian Subjects with a Fitzpatrick skin type of III to VI must present with facial hyperpigmentation and dark spots such as tan, pimple marks, sunspots, age spots, uneven skin tone on both side of face at baseline. Participants will be randomized in a 1:1 ratio to received either test Product A or test Product B. the study aims to complete evaluation for 50 Indian Subjects (25 Subjects per Test Product). The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be contacted telephonically by recruiting department prior to the screening. There will be total of 3 visits during the study. The duration of the study will be 90 Days (12 weeks) from the enrolment. Subjects will be instructed to visit the facility as per below visits: * Visit: 01 (Day 01, Week 00): Screening, ICD obtained, Enrolment, Baseline readings. * Visit 02 (Day 45, Week 06): Product Phase, Evaluations * Visit 03 (Day 90, Week 12): Evaluations and Product Phase end \| End of Study Assessments of Efficacy Parameters before test product(s) usage will be done on Day 01, and after usage of test product(s) on Day 45 (±2 Days) and Day 90(±2 Days)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Once Daily Route of administration: Oral Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight
Mode of Usage: Dissolve one effervescent tablet in a full glass of water in 200 mL. Allow it to fully dissolve before consuming. For best results, consume the solution immediately after preparation before the fizz ends. Frequency: Once Daily Route of administration: Oral Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight
NovoBliss Research Private Limited
Ahmedabad, Gujarat, India
Change in skin radiance measured by Glossymeter (Percent)
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in skin pigmentation and dark spots measured by Mexameter® MX 18 (Percent)
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in skin elasticity and firmness (R0 and R2 parameters) measured by Cutometer® Dual MPA 580 (Percentage)
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in skin hydration measured by Corneometer® CM 825 (Percentage)
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in oxidative stress marker Superoxide Dismutase (SOD) levels (U/mL)
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 90 (±2 days)
Change in inflammatory markers (C-Reactive Protein and Interleukin-6 [IL-6]) [pg/mL]
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 90 (±2 days)
Change in skin color parameters (L*, a*, b*, and ITA) measured by Skin Colorimeter CL 400 (values; ITA in degrees)
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Comparison of changes within each test product group and between product groups.
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in spot color intensity, average size (mm2) and number, pigmentation intensity, and contrast measured by Dermatological Evaluation using Modified Griffiths 10-point Scale
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in pigmentation intensity, spot surface area (mm2), and skin radiance measured by Image-Pro Analysis
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in melasma severity measured by Dermatological Evaluation using Melasma Area and Severity Index (MASI) (percentage)
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in visual skin appearance from facial photographs using Nikon Digital Camera D3300 or equivalent
Comparison of changes within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Change in subject-reported product perception (skin appearance, radiance, pigment reduction, glow, blemishes, and dark patch reduction) assessed by questionnaire
Comparison of responses within each test product group and between product groups
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)