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

NCT07162623 | Active Not Recruiting

• 1 other identifier: NB250030-ZV_1.0_06Aug25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperpigmentation

Keywords

dark spots; age spots; pimple spots; uneven skin tone

Outcome Measures

Primary Outcomes (2)

• Change in skin radiance measured by Glossymeter (Percent)

  Comparison of changes within each test product group and between product groups

  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

  Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)

Secondary Outcomes (10)

• Change in skin elasticity and firmness (R0 and R2 parameters) measured by Cutometer® Dual MPA 580 (Percentage)

  Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)

• Change in skin hydration measured by Corneometer® CM 825 (Percentage)

  Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)

• Change in oxidative stress marker Superoxide Dismutase (SOD) levels (U/mL)

  Baseline (Day 1) to Day 90 (±2 days)

• Change in inflammatory markers (C-Reactive Protein and Interleukin-6 [IL-6]) [pg/mL]

  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)

  Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)

Study Arms (2)

Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione

EXPERIMENTAL

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: Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione

Placebo Effervescent Tablets 4.1 g

EXPERIMENTAL

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

Interventions

Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione OTHER

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

Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione

Placebo Effervescent Tablets 4.1 g OTHER

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

Placebo Effervescent Tablets 4.1 g

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Age: 21 to 55 years (both inclusive) at the time of consent. 2) Sex: Adult male and female having facial hyperpigmentation and dark spots such as tan, pimple marks, sunspots, age spots, uneven skin tone on both side of face.
• \) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
• \) Subjects with Fitzpatrick Skin Types III to VI, indicating moderate to dark skin tones.
• \) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
• \) Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
• \) Subjects are not allowed to participate in any other study until this study is complete.
• \) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
• \) Subjects must agree to record each use of the test products in the subject's diary card on daily basis.
• \) Subjects must agree to record medication use during the study

You may not qualify if:

• \) Subjects who are on steroids for last six months. 2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last three months.
• \) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
• \) Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study.
• \) Subjects that are pregnant and/or breastfeeding. 6) The subject has a known allergy or sensitivity to product ingredients. 7) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
• \) The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
• \) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
• \) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Zywie Ventures Pvt Ltd: collaborator

Study Sites (1)

NovoBliss Research Private Limited

Ahmedabad, Gujarat, India

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nayan Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 9, 2025
• Study Start: September 2, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)