Clinical Study to Assess Safety, Efficacy and In-Use Tolerability of Oziva Bioactive Gluta Fizzy … (NCT07162623) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
India60 participantsStarted 2025-09-02
Plain-language 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.
Who can participate
Age range21 Years – 55 Years
SexALL
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Inclusion Criteria:
* 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.
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
Exclusion Criteria:
* 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 derma…
What they're measuring
1
Change in skin radiance measured by Glossymeter (Percent)
Timeframe: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)
2
Change in skin pigmentation and dark spots measured by Mexameter® MX 18 (Percent)
Timeframe: Baseline (Day 1) to Day 45 (±2 days) and Day 90 (±2 days)