Efficacy and Tolerability of an Isobutylamido-thiazolyl-resorcinol Cream 0.2% for Facial Hyperpigmentation, A Randomized Double-blind and Vehicle-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Patient's Global Assessment of facial hyperpigmentation will be evaluated every visit.
研究概览
简要总结
Facial hyperpigmentation is a common skin issue that can cause embarrassment and affect the quality of life in majority of people. The investigators are conducting a research to study an efficacy and tolerability of Isobutylamido-thiazolyl-resorcinol 0.2% in lightening of the facial hyperpigmentation in comparison to vehicle intervention in 4, 8 and 12-week period. The ultimate goal is to provide the best cosmetic cream to improve the quality of life of people who suffer from facial hyperpigmentation.
详细描述
Facial hyperpigmentation is a skin issue that occurs frequently in people with darker skin types. Studies show that the prevalence of facial hyperpigmentation is related to ethnicity and is accounted for up to 40%of the total population. The pathogenesis of facial hyperpigmentation is still unclear, but several factors seem to contribute such as ultraviolet radiation, female hormones, and genetics, which increase melanin production in the skin cells, specifically the epidermal melanocyte, and dermal melanophage. Hyperpigmentation can be embarrassing and affect the quality of life in the pertained individuals.
Tyrosinase enzyme plays a key element in melanin production which causes dark areas. In 2018, several studies have reported a new cosmetic product using Isobutylamido-thiazolyl-resorcinol (Beiersdorf AG, Hamburg, Germany) in facial hyperpigmentation. In vitro studies found that in melanocyte culture, Isobutylamido-thiazolyl-resorcinol inhibit melanin production. Studies discovered that Isobutylamido-thiazolyl-resorcinol 0.2% can reduce facial hyperpigmentation within 4 weeks. Hyperpigmentation begin to fade away within 12 weeks of daily application.
The objective is to study efficacy and tolerability of a cosmetic formulation with Isobutylamido-thiazolyl-resorcinol 0.2% compared to its vehicle in facial hyperpigmentation after 4, 8 and 12-week.
This is a randomized double-blind and vehicle-controlled study. Two hundred subjects both male and female 18 years or older with facial hyperpigmentation are recruited in the study. The study was performed at the Institute of Dermatology, Bangkok, Thailand. Subjects agree to attend monthly sessions every 4 weeks for 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are Thai adults age 18 years old and above .
- •Subjects suffer from facial hyperpigmentation for at least 10 years, with or without freckles, lentigo or dark sports.
- •Subjects must be able to attend monthly sessions in the period of 12 weeks session.
- •Subjects must refrain from using other whitening cream such as hydroquinone, azelaic acid, kojic acid, arbutin, glycolic acid or any other creams which whiten the skin including chemical peel or whitening pills such as Tranexamic acid at least 1 month before the trial.
- •Subjects must refrain from receiving both ablative and nonablative laser treatment at least 3 months before the trial.
- •Subjects who can apply sun screen with UVA and UVB protection that has a minimum of SPF30 daily.
排除标准
- •Subjects who have conditions such as Lichen planus pigmentosus, Pigmented contact dermatitis, Photosensitivity, Ashy dermatosis, Dermal melanosis, e.g. Nevus of Hori, Nevus of Ota, Dermal melanocyte hamartoma
- •Subjects with a congenital disease which darkens skin tone, e.g. Addison's disease, Cushing's syndrome and Thyrotoxicosis
- •Subjects with a congenital or serious disease with unpredictable symptoms such as Cirrhosis, cardiovascular diseases, Neurological diseases, gastrointestinal disease, Reproductive system diseases, Cancer and Psychiatric diseases.
- •Subjects who take pills that might cause hyperpigmentation such as chemotherapy, Amiodarone, Chlorpromazine, Hydroxychloroquine, Gold, Birth control pills (if related to causing hyperpigmentation issue)
- •Female subjects with pregnancy and breastfeeding.
- •Subjects who are allergic to chemical compound in the cream such as Alcohol denat, Phenoxyethanol or fragrance.
结局指标
主要结局
Patient's Global Assessment of facial hyperpigmentation will be evaluated every visit.
时间窗: 12 weeks
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Patient's Self-Grading of facial hyperpigmentation will be evaluated every visit.
时间窗: 12 weeks
Visual self-grading by patients from 1 to 10 by 1 is the least and 10 is the most in the criteria of evenness, spots and skin clarity
Color assessment of facial hyperpigmentation by Color Analysis program will be evaluated every visit.
时间窗: 12 weeks
Each visit, photos are taken on all patients by VISIA-CR system camera on 3 positions of the face, straight and 37\* on both sides with standard unfiltered and cross polarized lens. Each time the photos are filed and the colors are analyzed in order to be compared the changes between visits.
Physician's Global Assessment of facial hyperpigmentation will be evaluated every visit.
时间窗: 12 weeks
Evaluate the changes of facial hyperpigmentation by global assessment score: 0=Completely clear,1=Almost clear, 2=Marked improved, 3=Moderate improved, 4=Slight improved, 5=No change, 6=Worse
Evaluate side effects of Isobutylamido-thiazolyl-resorcinol cream 0.2% or vehicle cream every visit.
时间窗: 12 weeks
All patients are asked about the side effects of using the cream such as eczema, hypopigmentation, and redness.
次要结局
未报告次要终点
研究者
Chinmanat Lekhavat
Assistant Director
Institute of Dermatology, Thailand