Efficacy of Extract of Trigonella Foenum-graceum (Fenugreek) as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women : A Study of COL1A1, COL3A1, Skin Thickness, and Skin Wrinkles
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- High Resolution Ultrasound
研究概览
简要总结
Skin is subjected to intrinsic aging and extrinsic aging. Intrinsic aging is influenced by genetic and hormonal factors. Estrogen has significant role in modulating skin physiology. In post menopausal women, skin aging is accelerated because of hypoestrogenism. Administration of estrogen can delay the process of skin aging. Phytoestrogens are estrogen-like compounds which can be found naturally in plants. The investigators intend to study the efficacy of Trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women.
详细描述
In this double-blinded unmatched randomized controlled trial, the investigators intend to study the efficacy of Trigonella foenum-graceum extract as topical phytoestrogen in skin aging treatment of post menopausal women. The investigators have gathered 21 participants that will be divided into 2 groups, experimental group and control group. Experimental group will get treatment with topical cream containing Trigonella foenum-graceum extract, while control group will get treatment with placebo cream.
The study will be held in esthetic cluster, Kencana Cipto Mangunkusumo Hospital, and radiology cluster, Kencana Cipto Mangunkusumo Hospital from August 2019 until November 2019.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding is done to the participants, care providers, investigator, and outcomes assessor in every stage of the study.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with minimum 2 years post menopausal and maximum 8 years post menopausal
- •Have skin aging problems that manifested as wrinkles on forehead, crow's feet, and nasolabial fold region
- •Estradiol level < 30 pg/mL
- •Willing to terminate the routine use of facial cream or treatment during the study duration and at least for 30 days before the study commence
- •Willing to follow the study protocol and sign the informed consent
排除标准
- •Dermatitis in the region of face
- •Using oral/topical hormonal supplement in the last 12 months
- •Using products containing retinoic acid or it's derivatives in the last 30 days
- •Underwent radiotherapy, facelift, dermabrasion, botox, or facial filler procedures in the last 5 years
- •Breast lump or other breast abnormality
- •History of cancer or malignancy
- •Vein thrombosis
- •History of hormonal contraception allergy
- •History of ovariectomy
研究组 & 干预措施
Experimental Group
The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.
干预措施: Trigonella foenum-graceum extract topical cream (Drug)
Experimental Group
The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.
干预措施: Facial Wash (Other)
Experimental Group
The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.
干预措施: Sunscreen Cream (Other)
Control Group
The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33
干预措施: Facial Wash (Other)
Control Group
The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33
干预措施: Sunscreen Cream (Other)
Control Group
The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33
干预措施: Placebo (Other)
结局指标
主要结局
High Resolution Ultrasound
时间窗: Change from initial visit dermis thickness at 12 weeks
High resolution ultrasound examination in bilateral cheek region to determine dermis thickness (in milimeter).
Visual Analogue Scale for Crow's Feet Wrinkles
时间窗: Change from initial visit VAS at 12 weeks
Visual Analogue Scale (VAS) to measure wrinkles in crow's feet region (Scale 0-6), with 0-2 categorized as mild wrinkling, 3-4 categorized as moderate wrinkling, and 5-6 categorized as severe wrinkling
Visual Analogue Scale for Nasolabial Wrinkles
时间窗: Change from initial visit VAS at 12 weeks
Visual Analogue Scale (VAS) to measure wrinkles in nasolabial region (Scale 0-6), with 0-2 categorized as mild wrinkling, 3-4 categorized as moderate wrinkling, and 5-6 categorized as severe wrinkling
Visual Analogue Scale for Forehead Wrinkles
时间窗: Change from initial visit VAS at 12 weeks
Visual Analogue Scale (VAS) to measure wrinkles in the forehead region (Scale 0-8, with 0-2 categorized as mild wrinkling, 3-5 categorized as moderate wrinkling, and 6-8 categorized as severe wrinkling)
次要结局
未报告次要终点
研究者
Shannaz Nadia Yusharyahya
Head of Geriatric Dermatology Division, Department of Dermatovenereology, Faculty of Medicine, Indonesia University
Indonesia University