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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33. |
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| Control Group | Placebo Comparator | The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigonella foenum-graceum extract topical cream | Drug | Topical cream containing Trigonella foenum-graceum extract |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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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.
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Blinding is done to the participants, care providers, investigator, and outcomes assessor in every stage of the study.
| Facial Wash | Other | Wardah brand facial wash |
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| Sunscreen Cream | Other | Parasol sunscreen cream SPF 33 |
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| Placebo | Other | Placebo topical cream |
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