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

What Was Tested

The trial (not phased) is built around Glutathione for hyperparathyroidism.

Oziva Bioactive Gluta Fizzy Effervescent tablets in subjects with facial hyperpigmentation and dark spots.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as other.

More on the Plan

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.

Who Took Part

Enrollment: 62 actual participants took part.

It was open to people of any sex aged from 21 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The hyperparathyroidism participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.

The Glutathione group and the comparison group ran side by side rather than switching.

Neither the hyperparathyroidism participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2025-09-02 with completion listed for 2026-04-15.

It ran at 1 site in India.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Change in skin radiance measured by Glossymeter (Percent) (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) (time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)).

It also tracked 10 secondary outcomes, for example Change in skin elasticity and firmness (R0 and R2 parameters) measured by Cutometer® Dual MPA 580 (Percentage), Change in skin hydration measured by Corneometer® CM 825 (Percentage), Change in oxidative stress marker Superoxide Dismutase (SOD) levels (U/mL), Change in inflammatory markers (C-Reactive Protein and Interleukin-6 [IL-6]) [pg/mL], Change in skin color parameters (L*, a*, b*, and ITA) measured by Skin Colorimeter CL 400 (values; ITA in degrees) and Change in pigmentation intensity, spot surface area (mm2), and skin radiance measured by Image-Pro Analysis.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 62 people with hyperparathyroidism.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, Hyperparathyroidism research.