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NCT Number: NCT04123743

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

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.

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Key information

Conditions

Skin Aging

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trigonella foenum-graceum extract topical cream

Drug

Topical cream containing Trigonella foenum-graceum extract

Facial Wash

Other

Wardah brand facial wash

Sunscreen Cream

Other

Parasol sunscreen cream SPF 33

Placebo

Other

Placebo topical cream

Primary outcomes

  1. Visual Analogue Scale for Forehead Wrinkles

    Time frame: 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)

  2. Visual Analogue Scale for Crow's Feet Wrinkles

    Time frame: 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

  3. Visual Analogue Scale for Nasolabial Wrinkles

    Time frame: 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

  4. High Resolution Ultrasound

    Time frame: Change from initial visit dermis thickness at 12 weeks

    High resolution ultrasound examination in bilateral cheek region to determine dermis thickness (in milimeter).

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2019
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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