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

Phase 1

Completed

• Conditions: Skin Aging
• Interventions: Other: Facial Wash; Drug: Trigonella foenum-graceum extract topical cream; Other: Sunscreen Cream; Other: Placebo

• Registration Number: NCT04123743
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-08-10
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Primary Completion: 2019-11-03
• Study Completion: 2019-11-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Facial Wash	The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33
Experimental Group	Trigonella foenum-graceum extract topical cream	The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.
Control Group	Sunscreen Cream	The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33
Experimental Group	Facial Wash	The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.
Experimental Group	Sunscreen Cream	The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.
Control Group	Placebo	The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33

Primary Outcome Measures

Name	Time	Method
High Resolution Ultrasound	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	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	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	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)

Trial Locations

Locations (1)

Faculty of Medicine, Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia