Combination of Oral and Topical Whitening Agents for Reducing Skin Pigmentation in Healthy Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Skin spots assessment
研究概览
简要总结
The goal of this study is to evaluate the safety and efficacy of a combination use of oral supplement and topical serum in improving skin pigmentation in healthy women. The main questions it aims to answer are:
Does combination use able to reduce the dark spot? Is there any adverse effect associate with the product use?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy Malaysian women.
- •Aged 30 - 60 years old.
- •Fitzpatrick skin type III-V
- •Exhibiting signs of skin pigmentation such as post-inflammatory hyperpigmentation, freckles and solar lentigines.
排除标准
- •Participants with melasma.
- •Pregnant, breastfeeding women, or those planning pregnancy during the study period.
- •Participants with documented chronic medical conditions such as kidney disease, diabetes, heart problems, liver disease, gastrointestinal disorders, and others.
- •Participants with documented autoimmune diseases.
- •Participants with inflammatory or allergic skin problems such as atopic dermatitis, rosacea, or psoriasis.
- •Use of topical agents for skin brightening within the past three months.
- •Consumption of food or supplement products containing L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, pine bark extract, or other similar supplements, as well as the use of topical products containing niacinamide, glycyrrhiza glabra (licorice) root extract, retinol, or other products for skin brightening or rejuvenation within three months prior to the study.
- •Undergoing any cosmetic procedures such as botox, laser and light treatment, facial surgery, or any procedures aimed at improving skin conditions (e.g., skin brightening, elasticity, wrinkles, pores) prior to the study.
- •Consumption of any medical or hormonal treatments that could interfere with the study results, such as isotretinoin, tranexamic acid, and others.
- •Allergy to any ingredients that may be found in the product.
研究组 & 干预措施
Oral supplement + Retinol serum
Oral supplement is the same as the other arm. Topical serum containing niacinamide, glycyrrhiza glabra (licorice) root extract, and retinol.
干预措施: oral supplement (Dietary Supplement)
Oral supplement + Retinol serum
Oral supplement is the same as the other arm. Topical serum containing niacinamide, glycyrrhiza glabra (licorice) root extract, and retinol.
干预措施: Retinol serum (Other)
Oral supplement
Oral supplement contain L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, and pine bark extract.
干预措施: oral supplement (Dietary Supplement)
结局指标
主要结局
Skin spots assessment
时间窗: Baseline, Week 6, Week 12
Changes in skin spots (assessed under polarized and UV light) are evaluated using the JANUS III Facial Skin Analysis System.
Skin brightening assessment
时间窗: Baseline, Week 6, Week 12
Changes in skin brightness (L value) are evaluated using the JANUS III Facial Skin Analysis System.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](12 weeks)
- Participants satisfaction(Week6, Week12)