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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To evaluate the effectiveness of the test product by assessing change in pigmentation and dark spots from baseline to post- product, within each product group and across product groups.
研究概览
简要总结
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.
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 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 andProduct Phase end | End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 21 to 55 years (both inclusive) at the time of consent.
- •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.
排除标准
- •Subjects who are on steroids for last six months.
- •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.
- •The subject has a known allergy or sensitivity to product ingredients.
- •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.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
结局指标
主要结局
1. To evaluate the effectiveness of the test product by assessing change in pigmentation and dark spots from baseline to post- product, within each product group and across product groups.
时间窗: 1. To evaluate the effectiveness of test products by assessing change in skin pigmentation and dark spots using Mexameter® MX 18 from baseline on Day 01 and post usage of test products on Day 45 and Day 90 and between product groups. | 2. To evaluate the effectiveness of test products by assessing change in skin radiance using skin Glossymeter from baseline on Day 01 and post usage of test products on Day 45 and Day 90 and between product groups.
2. To evaluate the effectiveness of the test product by assessing improvement in skin radiance from baseline to post-product, within each product group and across product groups.
时间窗: 1. To evaluate the effectiveness of test products by assessing change in skin pigmentation and dark spots using Mexameter® MX 18 from baseline on Day 01 and post usage of test products on Day 45 and Day 90 and between product groups. | 2. To evaluate the effectiveness of test products by assessing change in skin radiance using skin Glossymeter from baseline on Day 01 and post usage of test products on Day 45 and Day 90 and between product groups.
次要结局
- 1. To evaluate the effectiveness of the test product by assessing change in skin elasticity and firmness from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 2. To evaluate the effectiveness of the test product by assessing change in skin hydration from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 3. To evaluate the effectiveness of the test product by assessing change in oxidative stress markers – Superoxide Dismutase (SOD) from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 4. To evaluate the effectiveness of the test product by assessing change in inflammatory markers such as C-Reactive Protein and Interleukin-6 (IL-6) from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 5. To evaluate the effectiveness of the test product by assessing change in skin colour parameters — L, a, b, and ITA from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 6. To evaluate the effectiveness of the test product by assessing changes in spot colour intensity, average size and number, pigmentation intensity and contrasts from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 7. To evaluate the effectiveness of the test product by assessing changes in pigmentation intensity in terms of spots surface and skin radiance from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 8. To evaluate the effectiveness of the test product by assessing changes in melasma severity from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 9. To evaluate the effectiveness of the test product by assessing changes in facial photographs from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
- 10. To evaluate the effectiveness of the test product by assessing changes in product perception questionnaire from baseline to post-product, within each product group and across product groups.(At baseline on Day 01, Day 45 and Day 90)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited