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

Skin Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123743
• Other study ID #: 00001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 10, 2019
• Est. completion date: November 10, 2019

Study information

• Verified date: July 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 10, 2019
• Est. primary completion date: November 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Aging

Intervention

Drug:
• Trigonella foenum-graceum extract topical cream
Topical cream containing Trigonella foenum-graceum extract

Other:
• Facial Wash
Wardah brand facial wash
• Sunscreen Cream
Parasol sunscreen cream SPF 33
• Placebo
Placebo topical cream

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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