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

University of Indonesia (UI)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Skin Aging

Treatments: Other: Placebo; Drug: Trigonella foenum-graceum extract topical cream; Other: Facial Wash; Other: Sunscreen Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04123743

00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.

Treatment:

Other: Facial Wash

Other: Sunscreen Cream

Drug: Trigonella foenum-graceum extract topical cream

Control Group

Placebo Comparator group

Description:

The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33

Treatment:

Other: Placebo

Other: Facial Wash

Other: Sunscreen Cream