NCT07162623

Clinical Study to Assess Safety, Efficacy and In-Use Tolerability of Oziva Bioactive Gluta Fizzy Effervescent Tablets on Subjects With Facial Dark Spots Such as Pimple Marks, Sunspots, Age Spots and Uneven Skin Tone

A Randomized, Double-Blind, Placebo-Controlled, Two-Arms, Prospective, Single-Center Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Test Product i.e. Oziva Bioactive Gluta Fizzy in Subjects With Facial Hyperpigmentation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Hyperpigmentation

Interventions

Type	Name	Description
OTHER	Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione	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
OTHER	Placebo Effervescent Tablets 4.1 g	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

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-04-15
• Completion: 2026-04-15
• First posted: 2025-09-09
• Last updated: 2026-01-30

Locations

1 site across 1 country: India