Clinical trial NCT04123743: Efficacy of Extract of Trigonella Foenum-graceum as Topical Phytoestrogen in Skin Aging Treatment of Post Menopausal Women
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Skin Aging
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 21
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale for Forehead Wrinkles
timeFrame: Change from initial visit VAS at 12 weeks
measure: Visual Analogue Scale for Crow's Feet Wrinkles
timeFrame: Change from initial visit VAS at 12 weeks
measure: Visual Analogue Scale for Nasolabial Wrinkles
timeFrame: Change from initial visit VAS at 12 weeks
measure: High Resolution Ultrasound
timeFrame: Change from initial visit dermis thickness at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
state: DKI Jakarta
Study officials:
References: