A randomized, open label, interventional clinical study to assess the efficacy and safety of Orah Glo V for bright and radiant skin.
概览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- Orah Nutrichem Pvt. Ltd
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 1.The study will evaluate the efficacy of the treatment through multiple assessment tools.
概览
简要总结
Participants: 24 randomized into a single group
Inclusion Criteria:
- Female subjects, 18-45 years old (skin types IV to V).
- Diagnosed with Melasma, Post-acne pigmentation, Post-inflammatory hypermelanosis, Seborrhoeic melanosis, Photo tanning, or Frictional melanosis.
- No participation in any other clinical trial in the past 3 months.
Exclusion Criteria:
- Major treatment (e.g., topical hydroquinone, tretinoin, cryotherapy, laser, IPL) in the past 3 months.
- History of allergies to whitening products.
- Past history of atopic dermatitis.
- Frequent sun exposure >4 hours/day.
- Pregnant or lactating women.
- Hypersensitivity to any study formulation components.
- Any condition deemed inappropriate by the investigator for study inclusion.
Primary Outcome Measures:
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Hyperpigmentation Reduction: Mean decrease in darkness of the target area assessed by Investigator Global Assessment (IGA) at baseline and 4 weeks.
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Photo Damage: IGA assessment of photo damage at baseline and 4 weeks.
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Wrinkle Evaluation: Crow’s feet wrinkles assessed using the Bazin scale at baseline and 4 weeks.
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Skin Quality Assessment: Grading of radiance, smoothness, pigmentation, erythema, pore size, clarity, brightness, tone, luminosity, and complexion (1-10 scale).
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Skin Brightness & Wrinkle Reduction: Measured by Cutometer and Chromameter/Mexameter at baseline, Day 7, Day 14, and Day 28.
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Global Improvement: Self-assessment and investigator evaluation of overall improvement (improved, unchanged, or deteriorated) at the end of the study.
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Efficacy Scoring: Investigator’s assessment of treatment efficacy (0 = no effect, 1 = poor, 2 = reasonable, 3 = good, 4 = excellent).
Secondary Outcome Measure:
- Monitoring of adverse events and assessment of quality of life during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Female subjects who are 18 to 45 years of age.
- •(skin types IV to V) 2.Patients with Melasma, Post acne pigmentation, post inflammatory hypermelanosis, Seborrhoeic melanosis, Photo tanning and Frictional melanosis will be included.
- •3.Subjects not have participated in any other clinical trial during the past 3 months.
排除标准
- •1.Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electrosurgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study 2.Past history of allergy to whitening cosmetic products 3.Past history of atopic dermatitis 4.Habit of frequent sun exposure longer than 4 hours per day 5.Pregnant or lactating women.
- •6.Hypersensitivity to any of the components of the test formulation.
- •7.The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
结局指标
主要结局
1.The study will evaluate the efficacy of the treatment through multiple assessment tools.
时间窗: Visit 1 - Day 1 | Visit 2 - Day 7 | Visit 3 - Day 14 | Visit 4 - Day 28
2.The investigator will measure the mean reduction in hyperpigmentation at baseline and after 4 weeks using the Investigator Global Assessment (IGA).
时间窗: Visit 1 - Day 1 | Visit 2 - Day 7 | Visit 3 - Day 14 | Visit 4 - Day 28
3.Photo damage will also be evaluated with IGA at both time points.
时间窗: Visit 1 - Day 1 | Visit 2 - Day 7 | Visit 3 - Day 14 | Visit 4 - Day 28
4.Crows feet wrinkles will be assessed using Bazins scale at baseline and week 4.
时间窗: Visit 1 - Day 1 | Visit 2 - Day 7 | Visit 3 - Day 14 | Visit 4 - Day 28
5.Skin quality will be assessed by both the investigator and the subject, focusing on radiance, smoothness, pigmentation, and other factors, with scores ranging from 1 to 10.
时间窗: Visit 1 - Day 1 | Visit 2 - Day 7 | Visit 3 - Day 14 | Visit 4 - Day 28
6.Skin brightness and wrinkle reduction will be measured using Cutometer and Chromameter or Mexameter at baseline, week 1, 2, and 4.
时间窗: Visit 1 - Day 1 | Visit 2 - Day 7 | Visit 3 - Day 14 | Visit 4 - Day 28
7.Global improvement will be evaluated by the subject and investigator through self-assessment and photographs. Based on primary outcomes, the treatment’s efficacy will be scored from 0 (no effect) to 4 (excellent effect).
时间窗: Visit 1 - Day 1 | Visit 2 - Day 7 | Visit 3 - Day 14 | Visit 4 - Day 28
次要结局
- To monitor for any adverse events during the study period and assess quality of life
研究者
Dr Roshany
DK Elite Health Care Centre