HyperpigmentationNCT07162623
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 study testing Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione in people with Hyperpigmentation, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Hyperpigmentation
- What is being tested?
- Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- 2 Sep 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) 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.
- 3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- 4) Subjects with Fitzpatrick Skin Types III to VI, indicating moderate to dark skin tones.
- 5) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
- 6) Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
- 7) Subjects are not allowed to participate in any other study until this study is complete.
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- 8) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
- 9) Subjects must agree to record each use of the test products in the subject's diary card on daily basis.
- 10) Subjects must agree to record medication use during the study
Who cannot join
- 1) 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.
- 3) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
- 4) Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study.
- 5) 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.
- 8) 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.
- 9) 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.
- 10) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
- 11) Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione, Placebo Effervescent Tablets 4.1 g
- Keywords
- dark spots, age spots, pimple spots, uneven skin tone
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing GlutathioneOther
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 gOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Placebo Effervescent Tablets 4.1 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin radiance measured by Glossymeter (Percent)
Comparison of changes within each test product group and between product groups
Measured: 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
Measured: 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)
Comparison of changes within each test product group and between product groups
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Comparison of changes within each test product group and between product groups.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start2 Sep 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Zywie Ventures Private Ltd.
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162623
- Sponsor's protocol ID
- NB250030-ZV_1.0_06Aug25
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07162623
- Acronym / sponsor ID
- NB250030-ZV_1.0_06Aug25
- Conditions
- Hyperpigmentation
- Keywords
- dark spots, age spots, pimple spots, uneven skin tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Zywie Ventures Private Ltd.
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione | Experimental | Other: Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing GlutathioneMode 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 | Experimental | Other: Placebo Effervescent Tablets 4.1 gMode 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. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 1) 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.
- 3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- 4) Subjects with Fitzpatrick Skin Types III to VI, indicating moderate to dark skin tones.
- 5) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
- 6) Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
Key exclusion criteria (8 listed)
- 1) 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.
- 3) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
- 4) Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study.
- 5) 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.
- 8) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing GlutathioneMode 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 gMode 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 |
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)
Comparison of changes within each test product group and between product groups
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)
Comparison of changes within each test product group and between product groups
10 secondary outcomes
Change in skin elasticity and firmness (R0 and R2 parameters) measured by Cutometer® Dual MPA 580 (Percentage)
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)
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)
Time frame: Baseline (Day 1) to Day 90 (±2 days)
Change in inflammatory markers (C-Reactive Protein and Interleukin-6 [IL-6]) [pg/mL]
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)
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
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
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)
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
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
Time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayan Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oziva Bioactive Gluta Fizzy Effervescent Tablets 4.1 g containing Glutathione in people with Hyperpigmentation, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin radiance measured by Glossymeter (Percent) (time frame: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.