A Clinical Usage Study to Evaluate the Safety and Efficacy of an Herbal-Based De-Pigmenting System
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Melanin Index
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and tolerability of an herbal de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to the other side of the face in treating mottled hyperpigmentation and melasma.
详细描述
This clinical study is being conducted in order to evaluate the effectiveness and tolerability of a de-pigmenting regimen when used by subjects with mild to severe mottled hyperpigmentation and melasma. Efficacy will be assessed using visual grading, device measurements and digital photography. Tolerance and safety will be evaluated by grading for objective and subjective signs of irritation, and the incidence and severity of adverse events. Efficacy and tolerance of this product are compared to that of Hydroquinone, which is applied to one side of the subject's face while the herbal de-pigmenting regimen is applied to the other side of the face.
The two product pigmentation reducing herbal regimen is based on the novel concept of inhibiting all 14 major and the 3 branch steps in the melanin cascade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female age 30-65
- •Must be in good general health
- •Must be willing to use sunscreen on the face daily
- •Must be willing to avoid tanning beds and excessive exposure to direct sunlight
- •Must be willing to continue using regular cosmetic regimen
排除标准
- •Nursing pregnant/ planning to become pregnant during the course of the study
- •Using a medication that increases sensitivity to sunlight including doxycycline, minocycline, tetracycline, ciprofloxin, hydrochlorothiazide, and sulfonamides.
- •Any known allergies/sensitivities to facial skincare products, anti-aging products, de-pigmenting products, or products containing hydroquinone
- •Usage of any new skincare products during the course of the study
- •Presence of atopic dermatitis or psoriasis on the face
- •Uncontrolled diabetes, hypertension, hypothyroidism, hyperthyroidism
- •TCA or other deep peels within 1 year or medium to light peels within 3 months prior to starting the study
- •Facial/laser treatment within the last 3 months
- •Facial cosmetic surgery within the last 12 months
- •Use of product, topical, or systemic medication, known to affect dyschromia, having "whitening" or anti-aging properties
- •Physical skin conditions such as excessive hair, scarring, tattoos that might impair evaluations of the test sites
- •Active hepatitis, immune deficiency, or autoimmune disease
研究组 & 干预措施
4% Hydroquinone
4% hydroquinone applied to one side of the face.
干预措施: Hydroquinone (Drug)
Herbal depigmenting agent
Herbal depigmenting agent applied on the other side of the face.
干预措施: Herbal depigmenting agent (Epionce) (Other)
结局指标
主要结局
Melanin Index
时间窗: 6 months
The melanin index of the skin will be measured at baseline and at each follow-up visit with a non-invasive device. At the end of the study, the change of the Melanin index over a period of 6 months will be calculated.
次要结局
- Irritation(Baseline, 1 month, 2 month, 4 month, 6 months)