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

July 28, 2020 updated by: Shannaz Nadia Yusharyahya, Indonesia University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale for Forehead Wrinkles
Time Frame: Change from initial visit VAS at 12 weeks
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
Time Frame: Change from initial visit VAS at 12 weeks
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
Time Frame: Change from initial visit VAS at 12 weeks
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
Time Frame: Change from initial visit dermis thickness at 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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