Efficacy of Extract of Trigonella Foenum-graceum as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Skin Aging

Intervention / Treatment
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* Drug: Trigonella foenum-graceum extract topical cream
* Other: Facial Wash
* Other: Sunscreen Cream
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants will be divided into 2 groups, experimental group and control group. Experimental group will get intervention with topical cream containing Trigonella foenum-graceum extract, while control group will get intervention with placebo topical cream. Both experimental and control group will receive Wardah brand facial wash and Parasol sunscreen SPF 33 as part of the assigned intervention as well.The participants will undergo the assigned intervention for 12 weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33. | Drug: Trigonella foenum-graceum extract topical cream<br>* Topical cream containing Trigonella foenum-graceum extract<br>Other: Facial Wash<br>* Wardah brand facial wash<br>Other: Sunscreen Cream<br>* Parasol sunscreen cream SPF 33<br>|
| Placebo Comparator: Control Group<br>The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33 | Other: Facial Wash<br>* Wardah brand facial wash<br>Other: Sunscreen Cream<br>* Parasol sunscreen cream SPF 33<br>Other: Placebo<br>* Placebo topical cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for Forehead Wrinkles | 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) | Change from initial visit VAS at 12 weeks | 
| Visual Analogue Scale for Crow's Feet Wrinkles | 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 | Change from initial visit VAS at 12 weeks | 
| Visual Analogue Scale for Nasolabial Wrinkles | 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 | Change from initial visit VAS at 12 weeks | 
| High Resolution Ultrasound | High resolution ultrasound examination in bilateral cheek region to determine dermis thickness (in milimeter). | Change from initial visit dermis thickness at 12 weeks |