None listed
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Indian male and female participants aged 18-50 years. 2. Fitzpatrick Skin Types I-IV. 3. Presence of visible facial dark spots and pigmentation. 4. Healthy face skin free of eczema, wounds, and inflammatory scars. 5. Absence of signs of infectious and evolutive pathology. 6. Willing to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Participants with chronic dermatosis or cutaneous hypersensitivity. 2. Clinically significant systemic or cutaneous disease, chronic illness, or recent major surgery. 3. Allergy or sensitivity to specified products or substances. 4. Pregnant or breastfeeding women, or use of hormonal birth control. 5. Recent participation in another clinical trial. 6. Current medication influencing study interpretation. 7. Unwillingness to discontinue other facial products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Overall hyperpigmentation, skin tone, tactile smoothness, brightness, and radiance. 2) Improvement in skin brightness and investigator s assessment on skin brightness, tone, smoothness, glow ,radiance, colour. 3) Measurement of skin tone , UV pigmentation, dark spots, pores and wrinkles. 4) Skin colour assessment using Colori Probe. 5) TEWL, Elasticity, and Hydration assessments using DermaLab Probes. 6) Change in tyrosinase biomarker level.Timepoint: Day 0, Day 15, Day 30, Day 60 & Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Record any change in vital signs (blood pressure, pulse rate, body temperature). 2. Record any change in CBS parameters, Liver Function Test (LFT), Renal Function Test (RFT) parameters and RBS. 3. Occurrence of the treatment-related adverse events (AEs) during study period. 4. Subjective assessment of treatment satisfaction, and perception regarding changes in skin brightness, whiteness, and pigmentation.Timepoint: Day 0, Day 15, Day 30, Day 60 & Day 90 | — |
Countries
India
Contacts
TrialGuna Private Limited