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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Drug: Trigonella foenum-graceum extract topical cream; Other: Facial Wash; Other: Sunscreen Cream; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Faculty of Medicine, Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; The experimental group will be given topical cream containing Trigonella foenum-graceum extract, Wardah brand facial wash, and Parasol sunscreen SPF 33.	Drug: Trigonella foenum-graceum extract topical cream; Topical cream containing Trigonella foenum-graceum extract; Other: Facial Wash; Wardah brand facial wash; Other: Sunscreen Cream; Parasol sunscreen cream SPF 33
PLACEBO_COMPARATOR: Control Group; The control / placebo group will be given placebo topical cream, Wardah brand facial wash, and Parasol sunscreen SPF 33	Other: Facial Wash; Wardah brand facial wash; Other: Sunscreen Cream; Parasol sunscreen cream SPF 33; Other: Placebo; Placebo topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2019
• Primary Completion (ACTUAL): November 3, 2019
• Study Completion (ACTUAL): November 10, 2019

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (ACTUAL): October 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 00001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No