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

NCT ID: NCT04123743

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2019-11-10

Brief Summary

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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

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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.

Conditions

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Skin Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Blinding is done to the participants, care providers, investigator, and outcomes assessor in every stage of the study.

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Trigonella foenum-graceum extract topical cream

Intervention Type DRUG

Topical cream containing Trigonella foenum-graceum extract

Facial Wash

Intervention Type OTHER

Wardah brand facial wash

Sunscreen Cream

Intervention Type OTHER

Parasol sunscreen cream SPF 33

Control Group

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

Group Type PLACEBO_COMPARATOR

Facial Wash

Intervention Type OTHER

Wardah brand facial wash

Sunscreen Cream

Intervention Type OTHER

Parasol sunscreen cream SPF 33

Placebo

Intervention Type OTHER

Placebo topical cream

Interventions

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Trigonella foenum-graceum extract topical cream

Topical cream containing Trigonella foenum-graceum extract

Intervention Type DRUG

Facial Wash

Wardah brand facial wash

Intervention Type OTHER

Sunscreen Cream

Parasol sunscreen cream SPF 33

Intervention Type OTHER

Placebo

Placebo topical cream

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Shannaz Nadia Yusharyahya

Head of Geriatric Dermatology Division, Department of Dermatovenereology, Faculty of Medicine, Indonesia University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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00001

Identifier Type: -

Identifier Source: org_study_id

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